A Phase 1 interventional study of Raltegravir and Raltegravir in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-03.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
The primary objective of this trial is to investigate effect of faldaprevir on steady state pharmacokinetics of raltegravir.
The assessment of safety and tolerability will be an additional objective of this trial.
Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
coated tablets, oral administration with 240 ml water
Drug: Raltegravir
coated tablets and soft gelatine capsule, oral administration with 240 ml water
Drug: Raltegravir · Drug: Faldaprevir
low dose oral administration
low dose oral administration
medium dose oral administration
AUC( Tau,ss)
AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated. The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'. RAL: Raltegravir , FDV: Faldaprevir
Time frame: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration
Cmax ,ss
C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated. The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'. RAL: Raltegravir , FDV: Faldaprevir
Time frame: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration
| Milestone | Overall Study |
|---|---|
| Started | 25 |
| Completed | 24 |
| Not completed | 1 |
| Withdrew: Not treated | 1 |
| Milestone | Overall Study |
|---|---|
| Started | 24 |
| Completed | 23 |
| Not completed | 1 |
| Withdrew: Consent withdrawn | 1 |
| Milestone | Overall Study |
|---|---|
| Started | 23 |
| Completed | 23 |
| Not completed | 0 |
AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated. The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'. RAL: Raltegravir , FDV: Faldaprevir
| ng*h/mL | Raltegravir | Raltegravir + Faldaprevir |
|---|---|---|
| AUC( Tau,ss) | 4070 ± 92.9 | 11100 ± 78.7 |
C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated. The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'. RAL: Raltegravir , FDV: Faldaprevir
| ng/mL | Raltegravir | Raltegravir + Faldaprevir |
|---|---|---|
| Cmax ,ss | 1300 ± 115 | 3220 ± 108 |
Collected over Up to 23 days (+1day). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Raltegravir | — | 0/24 (0%) | 6/24 (25%) |
| Raltegravir + Faldaprevir | — | 0/23 (0%) | 13/23 (56.5%) |
| Event | Raltegravir | Raltegravir + Faldaprevir |
|---|---|---|
| NauseaGastrointestinal disorders | 1/24 | 6/23 |
| HeadacheNervous system disorders | 3/24 | 5/23 |
| FatigueGeneral disorders | 0/24 | 5/23 |
| DiarrhoeaGastrointestinal disorders | 1/24 | 3/23 |
| VomitingGastrointestinal disorders | 0/24 | 2/23 |
| DizzinessNervous system disorders | 2/24 | 0/23 |
| FlatulenceGastrointestinal disorders | 2/24 | 1/23 |
The total number of participants N analysed for baseline characteristics is not same as the number of participants enrolled as one subject was not treated after being enrolled
| Age, Continuous(years) | Overall Study |
|---|---|
| Mean | 40.8 ± 8.8 |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 12 |
| Male | 12 |
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim