CompletedNCT01525628Updated Jun 10, 2016Results posted

Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients

A Phase 1 interventional study of midazolam and BI 201335 in Hepatitis C, Chronic, sponsored by Boehringer Ingelheim. Completed at 16 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-06-10.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment naive or prior treatment relapse patients with chronic hepatitis C infection.

Conditions studied

Hepatitis C, Chronic

Browse trials for

Hepatitis C, Chronic 1,090

In context

Hepatitis C, Chronic

1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.

This study's enrollment of 72 is below the median of 90 across 789 interventional studies indexed under Hepatitis C, Chronic.

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Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
Treatment naive or confirmed prior treatment relapse or partial response following treatment with interferon and ribavirin
Age 18 to 70 years
HCV RNA (Hepatitis C Virus RiboNucleic Acid) = 1,000 IU/mL at screening
Liver biopsy or fibroscan to exclude cirrhosis

Exclusion criteria

Exclusion criteria:

Hepatitis C Virus (HCV) infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
Decompensated liver disease, or history of decompensated liver disease,
Body weight \< 40 or > 125 kg,
Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
Laboratory parameters disorders (thalassemia major, sickle cell anemia or glucose 6 phosphate dehydrogenase deficit)
Hemoglobin \< 12 g/dL for women and \< 13 g/dL for men
Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 72 participants (actual)

Study arms

Experimental
Group A
Effect of BI 207127 on BI 201335, the effect of BI 201335 and dual oral direct acting antiviral (DAAs) on caffeine, tolbutamide and midazolam
Drug: tolbutamide · Drug: midazolam · Drug: caffeine · Drug: BI 201335 · Drug: pegylated interferon · Drug: BI 207127 · Drug: ribavirin
Experimental
Group B
Effect of BI 201335 on BI 207127, the effect of BI 207127 and metabolites and dual oral DAAs on caffeine, tolbutamide and midazolam
Drug: BI 201335 · Drug: caffeine · Drug: tolbutamide · Drug: pegylated interferon · Drug: BI 207127 · Drug: ribavirin · Drug: midazolam
Experimental
Group C
Effect of Dual oral DAAs on tenofovir
Drug: tenofovir · Drug: BI 207127 · Drug: ribavirin · Drug: BI 201335
Experimental
Group D
Effect of BI 201335 and BI 207127 at 600 mg b.i.d. on caffeine, tolbutamide and midazolam
Drug: midazolam · Drug: BI 201335 · Drug: BI 207127 · Drug: ribavirin · Drug: caffeine · Drug: tolbutamide
Experimental
Group E
Effect of BI 201335 and BI 207127 on raltegravir
Drug: BI 201335 · Drug: ribavirin · Drug: BI 207127

Interventions

Drugmidazolam
CYP3A probe drug
DrugBI 201335
HCV protease inhibitor
Drugtenofovir
nucleoside analogue
Drugcaffeine
CYP1A2 probe drug
Drugtolbutamide
CYP2C9 probe drug
Drugtolbutamide
CYP2C9 probe drug
Drugmidazolam
CYP3A probe drug
Drugcaffeine
CYP1A2 probe drug
Drugpegylated interferon
HCV treatment
DrugBI 201335
HCV protease inhibitor
DrugBI 201335
HCV protease inhibitor
DrugBI 207127
HCV polymerase inhibitor
DrugBI 207127
HCV polymerase inhibitor
DrugBI 201335
HCV protease inhibitor
DrugBI 207127
HCV polymerase inhibitor
Drugribavirin
HCV treatment
Drugribavirin
HCV treatment
Drugribavirin
HCV treatment
Drugpegylated interferon
HCV treatment
Drugribavirin
HCV treatment
Drugcaffeine
CYP1A2 probe drug
Drugtolbutamide
CYP2C9 probe drug
DrugBI 207127
HCV polymerase inhibitor
Drugmidazolam
CYP3A probe drug
DrugBI 201335
HCV protease inhibitor
DrugBI 207127
HCV polymerase inhibitor
Drugribavirin
HCV treatment

What researchers measure

Primary outcomes

Cmax of Faldaprevir (BI 201335)
Maximum concentration of an analyte in plasma
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
C24hr of Faldaprevir (BI 201335)
Concentration of an analyte in plasma at 24 hours
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Cmax of Deleobuvir (BI 207127)
Maximum concentration of an analyte in plasma
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
C6hr of Deleobuvir (BI 207127)
Concentration of an analyte in plasma at 6 hours
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
AUC 0-6hr of Deleobuvir (BI 207127)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
Maximum concentration of an analyte in plasma
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
Concentration of an analyte in plasma at 6 hours
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Cmax of Deleobuvir Reduction Metabolite CD 6168
Maximum concentration of an analyte in plasma
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
C6hr of Deleobuvir Reduction Metabolite CD 6168
Concentration of an analyte in plasma at 6 hours
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
Maximum concentration of an analyte in plasma
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
Concentration of an analyte in plasma at 6 hours
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Cmax of Caffeine
Maximum concentration of an analyte in plasma
Time frame: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
AUC 0-infinity of Caffeine
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Time frame: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Cmax of Tolbutamide
Maximum concentration of an analyte in plasma
Time frame: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
AUC 0-infinity of Tolbutamide
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Time frame: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Cmax of Midazolam
Maximum concentration of an analyte in plasma
Time frame: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
AUC 0-infinity of Midazolam
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Time frame: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)
Maximum concentration of an analyte in plasma
Time frame: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Time frame: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Cmax of Tenofovir
Maximum concentration of an analyte in plasma.
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17
C24hr of Tenofovir
Concentration of an analyte in plasma at 24 hours.
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17
AUC 0-24hr of Tenofovir
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours.
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17
Cmax of Raltegravir
Maximum concentration of an analyte in plasma.
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17
C12hr of Raltegravir
Concentration of an analyte in plasma at 12 hours.
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17
AUC 0-12hr of Raltegravir
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours.
Time frame: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17

Secondary outcomes

Number of Participants With Sustained Virological Response (SVR12)
Sustained virologic response (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL(international units per millilitre) undetectable at 12 weeks after the end of treatment. SVR12 was analyzed in a descriptive manner using frequency of participants who achieved SVR12.
Time frame: 12 weeks post treatment

Results

Posted Jun 10, 2016

Limitations and caveats

BI decided to stop the further development of the interferon-free combination therapy for Hepatitis C in December 2013 so the recruitment was stopped after 7 patients had entered Group E also PK analyses for Groups C to E were not performed.

Participant flow

72 patients were treated and analysed.

Participant flow — Overall Study
Milestone	Group A	Group B	Group C	Group D	Group E
Started	16	19	16	14	7
Completed	14	14	11	10	4
Not completed	2	5	5	4	3
Withdrew: Adverse event	1	1	2	0	1
Withdrew: Lack of efficacy	0	2	2	1	2
Withdrew: Protocol violation	0	0	1	0	0
Withdrew: Lost to follow-up	1	1	0	0	0
Withdrew: Withdrawal by subject	0	1	0	0	0
Withdrew: Other reason not defined above	0	0	0	3	0

Outcome measures

PrimaryCmax of Faldaprevir (BI 201335)

Maximum concentration of an analyte in plasma

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · ng/mL

Cmax of Faldaprevir (BI 201335)
ng/mL	Group A	Group B
Day 9 (N=15,0)	3520 ± 54.8	NA ± NA
Day 17 (N=14,14)	8780 ± 47.5	9950 ± 51.0
Day 66 (N=13,15)	4410 ± 48.7	6690 ± 78.8

Statistical analysis

Group A · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 251.37 · 90% CI 205.54 to 307.43Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.6514 · Ratio of gmeans day 66 vs. day 9 (%): 131.30 · 90% CI 105.40 to 163.57Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryC24hr of Faldaprevir (BI 201335)

Concentration of an analyte in plasma at 24 hours

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · ng/mL

C24hr of Faldaprevir (BI 201335)
ng/mL	Group A	Group B
Day 9 (N=15,0)	983 ± 65.5	NA ± NA
Day 17 (N=14,19)	3670 ± 90.4	5410 ± 91.6
Day 66 (N=13,14)	1140 ± 107	2580 ± 135

Statistical analysis

Group A · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 381.11 · 90% CI 317.01 to 458.19Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.4718 · Ratio of gmeans day 66 vs. day 9 (%): 123.65 · 90% CI 94.66 to 161.51Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryArea Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · ng*h/mL

Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours
ng*h/mL	Group A	Group B
Day 9 (N=15,0)	45600 ± 54.5	NA ± NA
Day 17 (N=14,19)	138000 ± 62.1	173000 ± 60.8
Day 66 (N=13,15)	56200 ± 58.2	97300 ± 114

Statistical analysis

Group A · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 306.45 · 90% CI 250.93 to 374.26Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.6185 · Ratio of gmeans day 66 vs. day 9 (%): 129.85 · 90% CI 104.26 to 161.71Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryCmax of Deleobuvir (BI 207127)

Maximum concentration of an analyte in plasma

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol/L

Cmax of Deleobuvir (BI 207127)
nmol/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	10900 ± 85.3
Day 17 (N=14, 19)	27000 ± 64.6	31400 ± 45.8
Day 66 (N=13, 15)	10100 ± 78.2	16000 ± 100

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 286.01 · 90% CI 228.51 to 357.97Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.8210 · Ratio of gmeans day 66 vs. day 9 (%): 150.45 · 90% CI 106.81 to 211.91Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryC6hr of Deleobuvir (BI 207127)

Concentration of an analyte in plasma at 6 hours

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol/L

C6hr of Deleobuvir (BI 207127)
nmol/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	5800 ± 129
Day 17 (N=14, 19)	17900 ± 84.2	20800 ± 83.8
Day 66 (N=13, 14)	5080 ± 108	10100 ± 133

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 349.90 · 90% CI 269.12 to 454.93Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9533 · Ratio of gmeans day 66 vs. day 9 (%): 176.56 · 90% CI 125.95 to 247.50Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryAUC 0-6hr of Deleobuvir (BI 207127)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol*h/L

AUC 0-6hr of Deleobuvir (BI 207127)
nmol*h/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	41100 ± 93.7
Day 17 (N=14, 19)	119000 ± 73.7	135000 ± 65.0
Day 66 (N=13, 15)	36200 ± 89.0	59200 ± 129

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 322.68 · 90% CI 256.24 to 406.34Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.7461 · Ratio of gmeans day 66 vs. day 9 (%): 145.93 · 90% CI 97.83 to 217.69Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryCmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)

Maximum concentration of an analyte in plasma

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol/L

Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
nmol/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	5620 ± 119
Day 17 (N=14, 19)	12700 ± 89.4	20200 ± 111
Day 66 (N=13, 15)	3790 ± 66.9	6550 ± 98.3

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 355.04 · 90% CI 298.13 to 422.83Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.4337 · Ratio of gmeans day 66 vs. day 9 (%): 120.67 · 90% CI 83.68 to 174.01Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryC6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)

Concentration of an analyte in plasma at 6 hours

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol/L

C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
nmol/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	4330 ± 154
Day 17 (N=14, 19)	11200 ± 83.7	17500 ± 119
Day 66 (N=13, 14)	2740 ± 85.9	5780 ± 132

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 397.73 · 90% CI 330.79 to 478.22Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.7346 · Ratio of gmeans day 66 vs. day 9 (%): 142.27 · 90% CI 99.49 to 203.44Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryAUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol*h/L

AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
nmol*h/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	24300 ± 131
Day 17 (N=14, 19)	61800 ± 97.9	98800 ± 124
Day 66 (N=13, 15)	15000 ± 81.2	27600 ± 128

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 403.86 · 90% CI 332.19 to 490.99Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.3968 · Ratio of gmeans day 66 vs. day 9 (%): 116.96 · 90% CI 75.38 to 181.47Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryCmax of Deleobuvir Reduction Metabolite CD 6168

Maximum concentration of an analyte in plasma

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol/L

Cmax of Deleobuvir Reduction Metabolite CD 6168
nmol/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	3040 ± 115
Day 17 (N=14, 19)	8520 ± 119	12400 ± 70.9
Day 66 (N=13, 15)	4510 ± 117	8880 ± 111

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 408.66 · 90% CI 315.15 to 529.90Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9993 · Ratio of gmeans day 66 vs. day 9 (%): 301.19 · 90% CI 204.61 to 443.35Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryC6hr of Deleobuvir Reduction Metabolite CD 6168

Concentration of an analyte in plasma at 6 hours

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol/L

C6hr of Deleobuvir Reduction Metabolite CD 6168
nmol/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	2250 ± 137
Day 17 (N=14, 19)	6980 ± 128	10200 ± 81.0
Day 66 (N=13, 14)	3360 ± 139	7460 ± 123

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 450.51 · 90% CI 343.67 to 590.57Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9996 · Ratio of gmeans day 66 vs. day 9 (%): 341.96 · 90% CI 229.22 to 510.13Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryAUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol*h/L

AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168
nmol*h/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	13300 ± 123
Day 17 (N=14, 19)	41700 ± 130	62200 ± 82.7
Day 66 (N=13, 15)	19300 ± 134	39100 ± 133

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 466.92 · 90% CI 357.02 to 610.66Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9972 · Ratio of gmeans day 66 vs. day 9 (%): 298.57 · 90% CI 187.22 to 476.15Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryCmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)

Maximum concentration of an analyte in plasma

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol/L

Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
nmol/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	203 ± 135
Day 17 (N=14, 19)	596 ± 143	1130 ± 115
Day 66 (N=13, 15)	386 ± 111	806 ± 125

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 528.95 · 90% CI 415.88 to 672.75Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9998 · Ratio of gmeans day 66 vs. day 9 (%): 384.00 · 90% CI 251.56 to 586.16Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryC6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)

Concentration of an analyte in plasma at 6 hours

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol/L

C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
nmol/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	159 ± 165
Day 17 (N=14, 19)	508 ± 138	962 ± 117
Day 66 (N=13, 14)	295 ± 128	712 ± 143

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 569.81 · 90% CI 447.49 to 725.57Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9999 · Ratio of gmeans day 66 vs. day 9 (%): 441.89 · 90% CI 286.81 to 680.82Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryAUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Reported as:: Geometric mean · nmol*h/L

AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
nmol*h/L	Group A	Group B
Day 9 (N=0, 17)	NA ± NA	893 ± 142
Day 17 (N=14, 19)	2980 ± 151	5700 ± 123
Day 66 (N=13, 15)	1620 ± 133	3510 ± 143

Statistical analysis

Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 9 (%): 606.29 · 90% CI 471.42 to 779.74Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9994 · Ratio of gmeans day 66 vs. day 9 (%): 377.98 · 90% CI 233.48 to 611.91Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryCmax of Caffeine

Maximum concentration of an analyte in plasma

Time frame:: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Reported as:: Geometric mean · ng/mL

Cmax of Caffeine
ng/mL	Group A	Group B
Day 1 (N=16, 19)	5170 ± 46.2	5340 ± 38.2
Day 9 (N=15, 17)	4890 ± 57.7	7220 ± 37.1
Day 17 (N=14, 19)	4830 ± 47.5	6530 ± 52.3
Day 66 (N=13, 15)	5590 ± 49.6	6450 ± 32.4

Statistical analysis

Group A · ANOVA · p = 0.0500 · Ratio of gmeans day 9 vs. day 1 (%): 97.03 · 90% CI 80.00 to 117.69Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.0564 · Ratio of gmeans day 17 vs. day 1 (%): 97.10 · 90% CI 79.37 to 118.79Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.2375 · Ratio of gmeans day 66 vs. day 1 (%): 114.38 · 90% CI 92.36 to 141.66Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9082 · Ratio of gmeans day 9 vs. day 1 (%): 139.07 · 90% CI 121.63 to 159.00Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.4111 · Ratio of gmeans day 17 vs. day 1 (%): 122.37 · 90% CI 104.11 to 143.84Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.3719 · Ratio of gmeans day 66 vs. day 1 (%): 121.43 · 90% CI 104.24 to 141.45Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryAUC 0-infinity of Caffeine

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.

Time frame:: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Reported as:: Geometric mean · ng*h/mL

AUC 0-infinity of Caffeine
ng*h/mL	Group A	Group B
Day 1 (N=16, 19)	54900 ± 130	77500 ± 119
Day 9 (N=15, 15)	42100 ± 96	142000 ± 109
Day 17 (N=14, 19)	71900 ± 169	170000 ± 203
Day 66 (N=13, 15)	120000 ± 220	159000 ± 138

Statistical analysis

Group A · ANOVA · p = 0.1037 · Ratio of gmeans day 9 vs. day 1 (%): 88.37 · 90% CI 77.39 to 100.89Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.8723 · Ratio of gmeans day 17 vs. day 1 (%): 159.11 · 90% CI 111.06 to 227.93Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.9830 · Ratio of gmeans day 66 vs. day 1 (%): 259.57 · 90% CI 150.65 to 447.21Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9689 · Ratio of gmeans day 9 vs. day 1 (%): 163.95 · 90% CI 129.52 to 207.52Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9933 · Ratio of gmeans day 17 vs. day 1 (%): 219.88 · 90% CI 153.84 to 314.26Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9865 · Ratio of gmeans day 66 vs. day 1 (%): 214.40 · 90% CI 145.88 to 315.09Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryCmax of Tolbutamide

Maximum concentration of an analyte in plasma

Time frame:: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Reported as:: Geometric mean · nmol/L

Cmax of Tolbutamide
nmol/L	Group A	Group B
Day 1 (N=16, 19)	152000 ± 30.8	170000 ± 18.6
Day 9 (N=15, 17)	146000 ± 28.1	158000 ± 22.8
Day 17 (N=14, 19)	130000 ± 24.7	126000 ± 32.0
Day 66 (N=13, 15)	110000 ± 32.3	127000 ± 25.0

Statistical analysis

Group A · ANOVA · p = 0.0015 · Ratio of gmeans day 9 vs. day 1 (%): 96.06 · 90% CI 87.77 to 105.13Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.1617 · Ratio of gmeans day 17 vs. day 1 (%): 85.41 · 90% CI 76.32 to 95.57Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.8930 · Ratio of gmeans day 66 vs. day 1 (%): 73.26 · 90% CI 65.03 to 82.54Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.0005 · Ratio of gmeans day 9 vs. day 1 (%): 92.23 · 90% CI 86.67 to 98.13Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.8646 · Ratio of gmeans day 17 vs. day 1 (%): 73.93 · 90% CI 65.55 to 83.39Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.8378 · Ratio of gmeans day 66 vs. day 1 (%): 75.42 · 90% CI 68.15 to 83.45Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryAUC 0-infinity of Tolbutamide

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.

Time frame:: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Reported as:: Geometric mean · nmol*h/L

AUC 0-infinity of Tolbutamide
nmol*h/L	Group A	Group B
Day 1 (N=16, 19)	1940000 ± 42.5	2220000 ± 29.4
Day 9 (N=13, 17)	1800000 ± 41.3	1940000 ± 36.5
Day 17 (N=14, 18)	1520000 ± 36.4	1410000 ± 27.9
Day 66 (N=12, 15)	1330000 ± 40.1	1390000 ± 33.2

Statistical analysis

Group A · ANOVA · p = 0.0005 · Ratio of gmeans day 9 vs. day 1 (%): 98.17 · 90% CI 90.15 to 106.91Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.3638 · Ratio of gmeans day 17 vs. day 1 (%): 81.26 · 90% CI 75.19 to 87.82Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.8975 · Ratio of gmeans day 66 vs. day 1 (%): 70.93 · 90% CI 60.44 to 83.22Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.1144 · Ratio of gmeans day 9 vs. day 1 (%): 86.37 · 90% CI 77.62 to 96.11Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 1.0000 · Ratio of gmeans day 17 vs. day 1 (%): 64.66 · 90% CI 60.42 to 69.20Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.9988 · Ratio of gmeans day 66 vs. day 1 (%): 63.75 · 90% CI 57.19 to 71.07Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryCmax of Midazolam

Maximum concentration of an analyte in plasma

Time frame:: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Reported as:: Geometric mean · nmol/L

Cmax of Midazolam
nmol/L	Group A	Group B
Day 1 (N=16, 19)	21.1 ± 38.3	23.8 ± 41.2
Day 9 (N=15, 17)	29.9 ± 34.7	29.8 ± 44.3
Day 17 (N=14, 19)	31.9 ± 36.6	28.8 ± 46.9
Day 66 (N=13, 15)	21.3 ± 34.0	23.2 ± 40.4

Statistical analysis

Group A · ANOVA · p = 0.9749 · Ratio of gmeans day 9 vs. day 1 (%): 144.78 · 90% CI 128.30 to 163.36Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.9703 · Ratio of gmeans day 17 vs. day 1 (%): 152.94 · 90% CI 128.60 to 181.89Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.0500 · Ratio of gmeans day 66 vs. day 1 (%): 102.99 · 90% CI 84.85 to 124.99Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.4697 · Ratio of gmeans day 9 vs. day 1 (%): 124.22 · 90% CI 107.91 to 142.99Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.2906 · Ratio of gmeans day 17 vs. day 1 (%): 120.74 · 90% CI 108.47 to 134.38Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.0460 · Ratio of gmeans day 66 vs. day 1 (%): 93.95 · 90% CI 80.33 to 109.86Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryAUC 0-infinity of Midazolam

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.

Time frame:: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Reported as:: Geometric mean · nmol*h/L

AUC 0-infinity of Midazolam
nmol*h/L	Group A	Group B
Day 1 (N=16, 19)	79.7 ± 59.1	107 ± 40.7
Day 9 (N=15, 17)	117 ± 58.2	130 ± 66.9
Day 17 (N=14, 19)	127 ± 50.2	140 ± 51.8
Day 66 (N=13, 15)	75.5 ± 46.7	95.6 ± 41.6

Statistical analysis

Group A · ANOVA · p = 0.9941 · Ratio of gmeans day 9 vs. day 1 (%): 151.66 · 90% CI 134.79 to 170.64Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.9926 · Ratio of gmeans day 17 vs. day 1 (%): 163.42 · 90% CI 137.91 to 193.64Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.0392 · Ratio of gmeans day 66 vs. day 1 (%): 98.14 · 90% CI 81.20 to 118.63Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.4374 · Ratio of gmeans day 9 vs. day 1 (%): 122.58 · 90% CI 99.15 to 151.55Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.6470 · Ratio of gmeans day 17 vs. day 1 (%): 130.44 · 90% CI 107.57 to 158.18Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.2372 · Ratio of gmeans day 66 vs. day 1 (%): 87.77 · 90% CI 70.32 to 109.54Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryCmax of 1-OH-Midazolam (1-hydroxy-midazolam)

Maximum concentration of an analyte in plasma

Time frame:: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Reported as:: Geometric mean · nmol/L

Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)
nmol/L	Group A	Group B
Day 1 (N=16, 19)	5.57 ± 36.4	6.68 ± 67.1
Day 9 (N=15, 17)	6.50 ± 46.3	6.52 ± 46.9
Day 17 (N=14, 19)	6.46 ± 42.7	5.02 ± 50.5
Day 66 (N=13, 15)	5.05 ± 45.6	4.67 ± 45.2

Statistical analysis

Group A · ANOVA · p = 0.1519 · Ratio of gmeans day 9 vs. day 1 (%): 117.67 · 90% CI 106.49 to 130.00Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.2827 · Ratio of gmeans day 17 vs. day 1 (%): 117.01 · 90% CI 96.06 to 142.52Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.1326 · Ratio of gmeans day 66 vs. day 1 (%): 92.11 · 90% CI 74.38 to 114.07Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.0432 · Ratio of gmeans day 9 vs. day 1 (%): 95.55 · 90% CI 80.63 to 113.24Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.7367 · Ratio of gmeans day 17 vs. day 1 (%): 75.19 · 90% CI 63.64 to 88.82Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.8547 · Ratio of gmeans day 66 vs. day 1 (%): 70.14 · 90% CI 56.84 to 86.56Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryAUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.

Time frame:: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Reported as:: Geometric mean · nmol*h/L

AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)
nmol*h/L	Group A	Group B
Day 1 (N=16, 19)	23.6 ± 59.8	26.0 ± 65.2
Day 9 (N=15, 17)	24.2 ± 35.9	28.5 ± 63.9
Day 17 (N=14, 19)	23.5 ± 37.4	22.8 ± 49.8
Day 66 (N=13, 13)	18.3 ± 26.7	20.8 ± 46.1

Statistical analysis

Group A · ANOVA · p = 0.1159 · Ratio of gmeans day 9 vs. day 1 (%): 102.70 · 90% CI 77.89 to 135.39Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.0651 · Ratio of gmeans day 17 vs. day 1 (%): 99.99 · 90% CI 78.33 to 127.64Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group A · ANOVA · p = 0.5658 · Ratio of gmeans day 66 vs. day 1 (%): 78.29 · 90% CI 62.50 to 98.07Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.1286 · Ratio of gmeans day 9 vs. day 1 (%): 108.25 · 90% CI 87.46 to 133.99Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.1898 · Ratio of gmeans day 17 vs. day 1 (%): 87.59 · 90% CI 73.56 to 104.30Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).
Group B · ANOVA · p = 0.5575 · Ratio of gmeans day 66 vs. day 1 (%): 78.42 · 90% CI 61.81 to 99.51Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).

PrimaryCmax of Tenofovir

Maximum concentration of an analyte in plasma.

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17

No measurements were reported for this outcome.

PrimaryC24hr of Tenofovir

Concentration of an analyte in plasma at 24 hours.

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17

No measurements were reported for this outcome.

PrimaryAUC 0-24hr of Tenofovir

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours.

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17

No measurements were reported for this outcome.

PrimaryCmax of Raltegravir

Maximum concentration of an analyte in plasma.

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17

No measurements were reported for this outcome.

PrimaryC12hr of Raltegravir

Concentration of an analyte in plasma at 12 hours.

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17

No measurements were reported for this outcome.

PrimaryAUC 0-12hr of Raltegravir

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours.

Time frame:: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17

No measurements were reported for this outcome.

SecondaryNumber of Participants With Sustained Virological Response (SVR12)

Sustained virologic response (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL(international units per millilitre) undetectable at 12 weeks after the end of treatment. SVR12 was analyzed in a descriptive manner using frequency of participants who achieved SVR12.

Time frame:: 12 weeks post treatment
Reported as:: Number · Participants

Number of Participants With Sustained Virological Response (SVR12)
Participants	Group A	Group B	Group C	Group D	Group E
Number of Participants With Sustained Virological Response (SVR12)	13	13	11	10	3

Adverse events

Collected over From first drug administration until last drug administration plus 28 days, up to 28 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group A	—	0/16 (0%)	16/16 (100%)
Group B	—	0/19 (0%)	19/19 (100%)
Group C	—	1/16 (6.3%)	16/16 (100%)
Group D	—	2/14 (14.3%)	14/14 (100%)
Group E	—	0/7 (0%)	5/7 (71.4%)

Most frequent serious events

Most frequent serious events
Event	Group A	Group B	Group C	Group D	Group E
Colitis ulcerativeGastrointestinal disorders	0/16	0/19	0/16	1/14	0/7
NauseaGastrointestinal disorders	0/16	0/19	0/16	1/14	0/7
Complex partial seizuresNervous system disorders	0/16	0/19	1/16	0/14	0/7
Acute psychosisPsychiatric disorders	0/16	0/19	1/16	0/14	0/7
Bipolar disorderPsychiatric disorders	0/16	0/19	1/16	0/14	0/7
Reactive psychosisPsychiatric disorders	0/16	0/19	1/16	0/14	0/7

Most frequent other events

Showing 10 of 239

Most frequent other events
Event	Group A	Group B	Group C	Group D	Group E
NauseaGastrointestinal disorders	12/16	16/19	12/16	10/14	2/7
PruritusSkin and subcutaneous tissue disorders	7/16	10/19	6/16	9/14	2/7
VomitingGastrointestinal disorders	5/16	11/19	7/16	5/14	1/7
FatigueGeneral disorders	9/16	11/19	8/16	8/14	2/7
HyperbilirubinaemiaHepatobiliary disorders	0/16	1/19	4/16	7/14	4/7
RashSkin and subcutaneous tissue disorders	6/16	7/19	5/16	0/14	4/7
HeadacheNervous system disorders	9/16	9/19	5/16	5/14	1/7
Photosensitivity reactionSkin and subcutaneous tissue disorders	9/16	8/19	2/16	0/14	0/7
DiarrhoeaGastrointestinal disorders	5/16	10/19	4/16	3/14	3/7
InsomniaPsychiatric disorders	8/16	5/19	3/16	0/14	0/7

Baseline characteristics

The treated set (TRT) included all patients who were dispensed trial medication and were documented to have taken at least one dose of trial drug.

Age, Continuous
Age, Continuous(Years)	Group A	Group B	Group C	Group D	Group E	Total
Mean	48.2 ± 12.3	53.6 ± 9.3	53.1 ± 9.5	48.4 ± 12.7	52.1 ± 10.4	51.1 ± 10.9

Sex: Female, Male
Sex: Female, Male(Participants)	Group A	Group B	Group C	Group D	Group E	Total
Female	7	8	5	7	1	28
Male	9	11	11	7	6	44

Study locations

16 sites

1241.27.0006 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
1241.27.0005 Boehringer Ingelheim Investigational Site
Rockville, Maryland, United States
1241.27.0004 Boehringer Ingelheim Investigational Site
Marlton, New Jersey, United States
1241.27.0003 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1241.27.0001 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
1241.27.0200 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1241.27.0600 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1241.27.0700 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1241.27.0400 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
1241.27.0100 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
1241.27.0300 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
1241.27.0500 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1241.27.4907 Boehringer Ingelheim Investigational Site
Cologne, Germany
1241.27.4901 Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
1241.27.4903 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1241.27.4906 Boehringer Ingelheim Investigational Site
Mainz, Germany

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01525628
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Feb 3, 2012
Start date: Apr 2012
Primary completion: Dec 2013
Completion: Oct 2014
Results posted: Jun 10, 2016
Last update: Jun 10, 2016

Study contacts

Boehringer Ingelheim

study chair · Boehringer Ingelheim

View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Midazolam · Faldaprevir · Tenofovir · Caffeine · Tolbutamide · Deleobuvir · Ribavirin

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