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CompletedNCT02661126Updated Jan 9, 2019Results posted

Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030)

A Phase 1 interventional study of MK-3682B in Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to compare the plasma pharmacokinetics (PK) of single doses of MK-3682B, a fixed dose combination (FDC) tablet containing uprifosbuvir (MK-3682) + grazoprevir (MK-5172) + ruzasvir (MK-8408) in participants with moderate (Part 1) and severe (Part 2) renal insufficiency (RI) to plasma PK in healthy participants.

02

Conditions studied

  • Hepatitis C
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 16 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

All Participants:

  • Healthy adult males or females 18-80 years of age at screening
  • Continuous non-smokers or moderate smokers (≤ 20 cigarettes/day or the equivalent) and agrees to consume no more than 10 cigarettes per day during the study period
  • BMI ≥ 18 and ≤ 40.0 kg/m\^2
  • Agrees not to become pregnant or father a child during participation in the study
  • Females of childbearing potential must either be abstinent for 14 days prior to dosing and throughout the study or be using an acceptable birth control method
  • Vasectomized or non-vasectomized males must agree to use a condom with spermicide or abstain from sexual intercourse from the first dose until 90 days after dosing
  • Males must agree not to donate sperm from dosing until 90 days after dosing

Moderate and Severe RI Participants:

  • Baseline health is judged to be stable based on medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the Investigator
  • Has had no clinically significant change in renal status at least 1 month prior to dosing and is not currently or has not previously been on hemodialysis
  • Moderate RI: has baseline eGFR ≥ 30 mL/min/1.73m\^2 and \< 60 mL/min/1.73m\^2, based on the Modification of Diet in Renal Disease (MDRD) equation at screening
  • Severe RI: has baseline eGFR ≥ 15 mL/min/1.73m\^2 and \< 30 mL/min/1.73m\^2, based on the MDRD equation at screening

Healthy Participants:

  • Is within ± 10 years of the mean age of moderate and severe RI arms
  • BMI is within 10% of the mean BMI of participants with moderate and severe RI arms
  • Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the Investigator
  • Baseline CLcr ≥ 80 mL/min based on Cockcroft-Gault equation at screening

Exclusion criteria

Exclusion Criteria:

  • Is mentally or legally incapacitated or has significant emotional problems at the time of the screening
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator
  • History of any illness that, in the opinion of the Investigator, might confound the results of the study or poses an additional risk by participating in the study
  • Is female and pregnant or lactating
  • Positive results for the urine or saliva drug screen or urine or breath alcohol screen at screening or check-in unless the positive drug screen is due to prescription drug use that is approved by the Investigator and Sponsor
  • Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
  • Seated heart rate is equal to or lower than 44 beats per minute (bpm) or higher than 100 bpm at screening
  • Has had a renal transplant or has had nephrectomy
  • Donation of blood or had significant blood loss within 56 days prior to dosing of study drug, or donation of plasma within 7 days prior to dosing
  • Has participated in another clinical trial within 28 days prior to dosing of study drug
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Moderate RI Participants

    Participants with an estimated glomerular filtration rate (eGFR) of ≥30 mL/min/1.73m\^2 to \<60 mL/min/1.73m\^2 take 2 MK-3682B FDC tablets on Day 1 after fasting for 10 hours.

    Drug: MK-3682B

  • Experimental
    Severe RI Participants

    Participants with an eGFR of ≥15 mL/min/1.73m\^2 to \<30 mL/min/1.73m\^2 take 2 MK-3682B FDC tablets on Day 1 after fasting for 10 hours.

    Drug: MK-3682B

  • Experimental
    Healthy Participants

    Healthy participants (creatinine clearance \[CLcr\] ≥80 mL/min) take 2 MK-362B FDC tablets on Day 1 after fasting for 10 hours. Healthy participants are matched to RI participants based on mean age, body mass index (BMI) and gender.

    Drug: MK-3682B

Interventions

  • DrugMK-3682B

    FDC oral tablet containing 225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir.

06

What researchers measure

Primary outcomes

  1. Area Under the Plasma Concentration-time Curve (AUC) From Dosing to Time of Last Measurable Concentration (AUC0-last) of Uprifosbuvir (MK-3682)

    AUC0-last is a measure of total exposure to uprifosbuvir in plasma from the start of dosing to the time of the last quantifiable (\< lower limit of quantification \[LLOQ\]) sample following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  2. AUC From Dosing to Infinity (AUC0-∞) of Uprifosbuvir

    AUC0-∞ is a measure of total exposure to uprifosbuvir in plasma from the start of dosing to infinity following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  3. AUC From Dosing to 24 Hours Post-dose (AUC0-24) of Uprifosbuvir

    AUC0-24 is a measure of total exposure to uprifosbuvir in plasma from dosing to 24 hours following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose

  4. Maximum Plasma Concentration (Cmax) of Uprifosbuvir

    Cmax is the maximum amount of uprifosbuvir in plasma following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  5. Plasma Concentration 24 Hours Post-dose (C24) of Uprifosbuvir

    C24 is the plasma concentration of uprifosbuvir 24 hours following oral administration of MK-3682B.

    Time frame: 24 hours post-dose

  6. Time to Reach Maximum Plasma Concentration (Tmax) of Uprifosbuvir

    Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  7. Apparent Total Body Clearance (CL/F) of Uprifosbuvir

    CL/F is the apparent total body clearance of uprifosbuvir following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  8. Apparent Volume of Distribution (Vz/F) of Uprifosbuvir

    Vz/F is the apparent volume of distribution of uprifosbuvir following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  9. Apparent Terminal Half-life in Plasma (t½) of Uprifosbuvir

    t1/2 is the amount of time required to clear 50% of uprifosbuvir from plasma following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  10. AUC0-last of Uprifosbuvir Metabolite M5

    AUC0-last is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  11. AUC0-∞ of Uprifosbuvir Metabolite M5

    AUC0-∞ is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from the start of dosing to infinity following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  12. AUC0-24 of Uprifosbuvir Metabolite M5

    AUC0-24 is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from dosing to 24 hours following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose

  13. Cmax of Uprifosbuvir Metabolite M5

    Cmax is the maximum amount of uprifosbuvir metabolite M5 in plasma following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  14. C24 of Uprifosbuvir Metabolite M5

    C24 is the plasma concentration of uprifosbuvir metabolite M5 24 hours following oral administration of MK-3682B.

    Time frame: 24 hours post-dose

  15. Tmax of Uprifosbuvir Metabolite M5

    Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir metabolite M5 following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  16. Lag Time (Tlag) of Uprifosbuvir Metabolite M5

    Tlag is the time from dosing to first appearance in plasma of uprifosbuvir metabolite M5 following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  17. t½ of Uprifosbuvir Metabolite M5

    t1/2 is the amount of time required to clear 50% of uprifosbuvir metabolite M5 from plasma following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  18. AUC0-last of Uprifosbuvir Metabolite M6

    AUC0-last is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  19. AUC0-∞ of Uprifosbuvir Metabolite M6

    AUC0-∞ is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from the start of dosing to infinity following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  20. AUC0-24 of Uprifosbuvir Metabolite M6

    AUC0-24 is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from dosing to 24 hours following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose

  21. Cmax of Uprifosbuvir Metabolite M6

    Cmax is the maximum amount of uprifosbuvir metabolite M6 in plasma following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  22. C24 of Uprifosbuvir Metabolite M6

    C24 is the plasma concentration of uprifosbuvir metabolite M6 24 hours following oral administration of MK-3682B.

    Time frame: 24 hours post-dose

  23. Tmax of Uprifosbuvir Metabolite M6

    Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir metabolite M6 following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  24. t½ of Uprifosbuvir Metabolite M6

    t1/2 is the amount of time required to clear 50% of uprifosbuvir metabolite M6 from plasma following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  25. AUC0-last of Grazoprevir (MK-5172)

    AUC0-last is a measure of total exposure to grazoprevir in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  26. AUC0-∞ of Grazoprevir

    AUC0-∞ is a measure of total exposure to grazoprevir in plasma from the start of dosing to infinity following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  27. AUC0-24 of Grazoprevir

    AUC0-24 is a measure of total exposure to grazoprevir in plasma from the start of dosing to 24 hours post-dose following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose

  28. Cmax of Grazoprevir

    Cmax is the maximum amount of grazoprevir in plasma following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  29. C24 of Grazoprevir

    C24 is the plasma concentration of grazoprevir 24 hours following oral administration of MK-3682B.

    Time frame: 24 hours post-dose

  30. Tmax of Grazoprevir

    Tmax is the time required to reach the maximum post-dose plasma concentration of grazoprevir following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  31. CL/F of Grazoprevir

    CL/F is the apparent total body clearance of grazoprevir following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  32. Vz/F of Grazoprevir

    Vz/F is the apparent volume of distribution of grazoprevir following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  33. t½ of Grazoprevir

    t1/2 is the amount of time required to clear 50% of grazoprevir from plasma following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  34. AUC0-last of Ruzasvir (MK-8408)

    AUC0-last is a measure of total exposure to ruzasvir in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  35. AUC0-∞ of Ruzasvir

    AUC0-∞ is a measure of total exposure to ruzasvir in plasma from the start of dosing to infinity following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  36. AUC0-24 of Ruzasvir

    AUC0-24 is a measure of total exposure to ruzasvir in plasma from dosing to 24 hours following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose

  37. Cmax of Ruzasvir

    Cmax is the maximum amount of ruzasvir in plasma following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  38. C24 of Ruzasvir

    C24 is the plasma concentration of ruzasvir 24 hours following oral administration of MK-3682B.

    Time frame: 24 hours post-dose

  39. Tmax of Ruzasvir

    Tmax is the time required to reach the maximum post-dose plasma concentration of ruzasvir following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  40. CL/F of Ruzasvir

    CL/F is the apparent total body clearance of ruzasvir following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  41. Vz/F of Ruzasvir

    Vz/F is the apparent volume of distribution of ruzasvir following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

  42. t½ of Ruzasvir

    t1/2 is the amount of time required to clear 50% of ruzasvir from plasma following oral administration of MK-3682B.

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose

07

Results

Posted Dec 14, 2018

Participant flow

In Part 1, adults with moderate renal impairment (RI; determined by estimated glomerular filtration rate \[eGFR\]), and healthy participants, were recruited at 2 sites in the US. Part 2 was intended to enroll severe RI participants but was not conducted based on results of a planned interim analysis of Part 1 data.

Participant flow — Overall Study
MilestoneModerate RI ParticipantsHealthy Participants
Started88
Completed88
Not completed00

Outcome measures

PrimaryArea Under the Plasma Concentration-time Curve (AUC) From Dosing to Time of Last Measurable Concentration (AUC0-last) of Uprifosbuvir (MK-3682)

AUC0-last is a measure of total exposure to uprifosbuvir in plasma from the start of dosing to the time of the last quantifiable (\< lower limit of quantification \[LLOQ\]) sample following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · uM*hr
Area Under the Plasma Concentration-time Curve (AUC) From Dosing to Time of Last Measurable Concentration (AUC0-last) of Uprifosbuvir (MK-3682)
uM*hrModerate RI ParticipantsHealthy Participants
Area Under the Plasma Concentration-time Curve (AUC) From Dosing to Time of Last Measurable Concentration (AUC0-last) of Uprifosbuvir (MK-3682)8.55 (6.22 to 11.8)4.23 (3.08 to 5.82)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-last in moderate ri/healthy: 2.02 · 90% CI 1.40 to 2.92
PrimaryAUC From Dosing to Infinity (AUC0-∞) of Uprifosbuvir

AUC0-∞ is a measure of total exposure to uprifosbuvir in plasma from the start of dosing to infinity following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC From Dosing to Infinity (AUC0-∞) of Uprifosbuvir
uM*hrModerate RI ParticipantsHealthy Participants
AUC From Dosing to Infinity (AUC0-∞) of Uprifosbuvir8.56 (6.24 to 11.7)4.28 (3.12 to 5.87)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-∞ in moderate ri/healthy: 2.00 · 90% CI 1.39 to 2.89
PrimaryAUC From Dosing to 24 Hours Post-dose (AUC0-24) of Uprifosbuvir

AUC0-24 is a measure of total exposure to uprifosbuvir in plasma from dosing to 24 hours following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC From Dosing to 24 Hours Post-dose (AUC0-24) of Uprifosbuvir
uM*hrModerate RI ParticipantsHealthy Participants
AUC From Dosing to 24 Hours Post-dose (AUC0-24) of Uprifosbuvir8.54 (6.22 to 11.7)4.24 (3.08 to 5.82)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-24 in moderate ri/healthy: 2.02 · 90% CI 1.39 to 2.92
PrimaryMaximum Plasma Concentration (Cmax) of Uprifosbuvir

Cmax is the maximum amount of uprifosbuvir in plasma following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · nM
Maximum Plasma Concentration (Cmax) of Uprifosbuvir
nMModerate RI ParticipantsHealthy Participants
Maximum Plasma Concentration (Cmax) of Uprifosbuvir3030 (2230 to 4110)1570 (1160 to 2130)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of cmax in moderate ri/healthy: 1.92 · 90% CI 1.35 to 2.74
PrimaryPlasma Concentration 24 Hours Post-dose (C24) of Uprifosbuvir

C24 is the plasma concentration of uprifosbuvir 24 hours following oral administration of MK-3682B.

Time frame:
24 hours post-dose
Reported as:
Median · nM
Plasma Concentration 24 Hours Post-dose (C24) of Uprifosbuvir
nMModerate RI ParticipantsHealthy Participants
Plasma Concentration 24 Hours Post-dose (C24) of Uprifosbuvir—3.65 (0.00 to 9.97)
PrimaryTime to Reach Maximum Plasma Concentration (Tmax) of Uprifosbuvir

Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Median · Hours
Time to Reach Maximum Plasma Concentration (Tmax) of Uprifosbuvir
HoursModerate RI ParticipantsHealthy Participants
Time to Reach Maximum Plasma Concentration (Tmax) of Uprifosbuvir1.00 (0.50 to 4.00)1.00 (0.50 to 2.00)
PrimaryApparent Total Body Clearance (CL/F) of Uprifosbuvir

CL/F is the apparent total body clearance of uprifosbuvir following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · Liters/hour
Apparent Total Body Clearance (CL/F) of Uprifosbuvir
Liters/hourModerate RI ParticipantsHealthy Participants
Apparent Total Body Clearance (CL/F) of Uprifosbuvir96.3 ± 51.5193 ± 34.7
PrimaryApparent Volume of Distribution (Vz/F) of Uprifosbuvir

Vz/F is the apparent volume of distribution of uprifosbuvir following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · Liters
Apparent Volume of Distribution (Vz/F) of Uprifosbuvir
LitersModerate RI ParticipantsHealthy Participants
Apparent Volume of Distribution (Vz/F) of Uprifosbuvir290 ± 51.7724 ± 115.2
PrimaryApparent Terminal Half-life in Plasma (t½) of Uprifosbuvir

t1/2 is the amount of time required to clear 50% of uprifosbuvir from plasma following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · Hours
Apparent Terminal Half-life in Plasma (t½) of Uprifosbuvir
HoursModerate RI ParticipantsHealthy Participants
Apparent Terminal Half-life in Plasma (t½) of Uprifosbuvir2.09 ± 65.62.60 ± 92.9
PrimaryAUC0-last of Uprifosbuvir Metabolite M5

AUC0-last is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-last of Uprifosbuvir Metabolite M5
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-last of Uprifosbuvir Metabolite M514.8 (11.1 to 19.6)7.62 (5.74 to 10.1)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-last in moderate ri/healthy: 1.94 · 90% CI 1.39 to 2.72
PrimaryAUC0-∞ of Uprifosbuvir Metabolite M5

AUC0-∞ is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from the start of dosing to infinity following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-∞ of Uprifosbuvir Metabolite M5
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-∞ of Uprifosbuvir Metabolite M516.2 (12.5 to 20.8)7.99 (6.19 to 10.3)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-∞ in moderate ri/healthy: 2.02 · 90% CI 1.50 to 2.74
PrimaryAUC0-24 of Uprifosbuvir Metabolite M5

AUC0-24 is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from dosing to 24 hours following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-24 of Uprifosbuvir Metabolite M5
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-24 of Uprifosbuvir Metabolite M54.59 (3.25 to 6.47)2.67 (1.89 to 3.77)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-24 in moderate ri/healthy: 1.72 · 90% CI 1.15 to 2.56
PrimaryCmax of Uprifosbuvir Metabolite M5

Cmax is the maximum amount of uprifosbuvir metabolite M5 in plasma following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · nM
Cmax of Uprifosbuvir Metabolite M5
nMModerate RI ParticipantsHealthy Participants
Cmax of Uprifosbuvir Metabolite M5321 (220 to 467)173 (119 to 252)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of cmax in moderate ri/healthy: 1.85 · 90% CI 1.20 to 2.87
PrimaryC24 of Uprifosbuvir Metabolite M5

C24 is the plasma concentration of uprifosbuvir metabolite M5 24 hours following oral administration of MK-3682B.

Time frame:
24 hours post-dose
Reported as:
Geometric mean · nM
C24 of Uprifosbuvir Metabolite M5
nMModerate RI ParticipantsHealthy Participants
C24 of Uprifosbuvir Metabolite M5262 (189 to 365)129 (93.0 to 180)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of c24 in moderate ri/healthy: 2.03 · 90% CI 1.38 to 2.97
PrimaryTmax of Uprifosbuvir Metabolite M5

Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir metabolite M5 following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Median · Hours
Tmax of Uprifosbuvir Metabolite M5
HoursModerate RI ParticipantsHealthy Participants
Tmax of Uprifosbuvir Metabolite M520.00 (10.00 to 24.00)13.00 (12.00 to 16.00)
PrimaryLag Time (Tlag) of Uprifosbuvir Metabolite M5

Tlag is the time from dosing to first appearance in plasma of uprifosbuvir metabolite M5 following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Median · Hours
Lag Time (Tlag) of Uprifosbuvir Metabolite M5
HoursModerate RI ParticipantsHealthy Participants
Lag Time (Tlag) of Uprifosbuvir Metabolite M52.00 (2.00 to 3.00)2.00 (2.00 to 3.00)
Primaryt½ of Uprifosbuvir Metabolite M5

t1/2 is the amount of time required to clear 50% of uprifosbuvir metabolite M5 from plasma following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · Hours
t½ of Uprifosbuvir Metabolite M5
HoursModerate RI ParticipantsHealthy Participants
t½ of Uprifosbuvir Metabolite M526.27 ± 45.025.33 ± 6.4
PrimaryAUC0-last of Uprifosbuvir Metabolite M6

AUC0-last is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-last of Uprifosbuvir Metabolite M6
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-last of Uprifosbuvir Metabolite M663.9 (50.1 to 81.5)33.5 (26.3 to 42.8)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-last in moderate ri/healthy: 1.91 · 90% CI 1.44 to 2.53
PrimaryAUC0-∞ of Uprifosbuvir Metabolite M6

AUC0-∞ is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from the start of dosing to infinity following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-∞ of Uprifosbuvir Metabolite M6
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-∞ of Uprifosbuvir Metabolite M671.4 (55.8 to 91.3)36.2 (28.3 to 46.2)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-∞ in moderate ri/healthy: 1.97 · 90% CI 1.48 to 2.63
PrimaryAUC0-24 of Uprifosbuvir Metabolite M6

AUC0-24 is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from dosing to 24 hours following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-24 of Uprifosbuvir Metabolite M6
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-24 of Uprifosbuvir Metabolite M627.2 (22.2 to 33.4)13.9 (11.3 to 17.1)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-24 in moderate ri/healthy: 1.96 · 90% CI 1.54 to 2.48
PrimaryCmax of Uprifosbuvir Metabolite M6

Cmax is the maximum amount of uprifosbuvir metabolite M6 in plasma following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · nM
Cmax of Uprifosbuvir Metabolite M6
nMModerate RI ParticipantsHealthy Participants
Cmax of Uprifosbuvir Metabolite M61540 (1210 to 1950)906 (715 to 1150)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of cmax in moderate ri/healthy: 1.70 · 90% CI 1.29 to 2.24
PrimaryC24 of Uprifosbuvir Metabolite M6

C24 is the plasma concentration of uprifosbuvir metabolite M6 24 hours following oral administration of MK-3682B.

Time frame:
24 hours post-dose
Reported as:
Geometric mean · nM
C24 of Uprifosbuvir Metabolite M6
nMModerate RI ParticipantsHealthy Participants
C24 of Uprifosbuvir Metabolite M6905 (712 to 1150)466 (367 to 592)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of c24 in moderate ri/healthy: 1.94 · 90% CI 1.47 to 2.57
PrimaryTmax of Uprifosbuvir Metabolite M6

Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir metabolite M6 following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Median · Hours
Tmax of Uprifosbuvir Metabolite M6
HoursModerate RI ParticipantsHealthy Participants
Tmax of Uprifosbuvir Metabolite M68.00 (3.00 to 10.00)3.50 (3.00 to 4.00)
Primaryt½ of Uprifosbuvir Metabolite M6

t1/2 is the amount of time required to clear 50% of uprifosbuvir metabolite M6 from plasma following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · Hours
t½ of Uprifosbuvir Metabolite M6
HoursModerate RI ParticipantsHealthy Participants
t½ of Uprifosbuvir Metabolite M633.58 ± 39.730.55 ± 19.7
PrimaryAUC0-last of Grazoprevir (MK-5172)

AUC0-last is a measure of total exposure to grazoprevir in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-last of Grazoprevir (MK-5172)
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-last of Grazoprevir (MK-5172)0.974 (0.523 to 1.81)0.730 (0.392 to 1.36)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-last in moderate ri/healthy: 1.33 · 90% CI 0.65 to 2.75
PrimaryAUC0-∞ of Grazoprevir

AUC0-∞ is a measure of total exposure to grazoprevir in plasma from the start of dosing to infinity following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-∞ of Grazoprevir
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-∞ of Grazoprevir1.32 (0.708 to 2.45)0.826 (0.463 to 1.48)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-∞ in moderate ri/healthy: 1.59 · 90% CI 0.79 to 3.19
PrimaryAUC0-24 of Grazoprevir

AUC0-24 is a measure of total exposure to grazoprevir in plasma from the start of dosing to 24 hours post-dose following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-24 of Grazoprevir
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-24 of Grazoprevir0.436 (0.218 to 0.875)0.380 (0.190 to 0.762)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-24 in moderate ri/healthy: 1.15 · 90% CI 0.51 to 2.57
PrimaryCmax of Grazoprevir

Cmax is the maximum amount of grazoprevir in plasma following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · nM
Cmax of Grazoprevir
nMModerate RI ParticipantsHealthy Participants
Cmax of Grazoprevir67.5 (31.0 to 147)54.7 (25.1 to 119)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of cmax in moderate ri/healthy: 1.23 · 90% CI 0.50 to 3.05
PrimaryC24 of Grazoprevir

C24 is the plasma concentration of grazoprevir 24 hours following oral administration of MK-3682B.

Time frame:
24 hours post-dose
Reported as:
Geometric mean · nM
C24 of Grazoprevir
nMModerate RI ParticipantsHealthy Participants
C24 of Grazoprevir9.41 (4.64 to 19.1)7.36 (3.63 to 14.9)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of c24 in moderate ri/healthy: 1.28 · 90% CI 0.56 to 2.91
PrimaryTmax of Grazoprevir

Tmax is the time required to reach the maximum post-dose plasma concentration of grazoprevir following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Median · Hours
Tmax of Grazoprevir
HoursModerate RI ParticipantsHealthy Participants
Tmax of Grazoprevir2.00 (1.00 to 4.00)2.25 (1.00 to 10.00)
PrimaryCL/F of Grazoprevir

CL/F is the apparent total body clearance of grazoprevir following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · Liters/hour
CL/F of Grazoprevir
Liters/hourModerate RI ParticipantsHealthy Participants
CL/F of Grazoprevir99.1 ± 122.0158 ± 57.9
PrimaryVz/F of Grazoprevir

Vz/F is the apparent volume of distribution of grazoprevir following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · Liters
Vz/F of Grazoprevir
LitersModerate RI ParticipantsHealthy Participants
Vz/F of Grazoprevir6030 ± 183.59750 ± 77.5
Primaryt½ of Grazoprevir

t1/2 is the amount of time required to clear 50% of grazoprevir from plasma following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · Hours
t½ of Grazoprevir
HoursModerate RI ParticipantsHealthy Participants
t½ of Grazoprevir42.21 ± 40.342.85 ± 26.4
PrimaryAUC0-last of Ruzasvir (MK-8408)

AUC0-last is a measure of total exposure to ruzasvir in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-last of Ruzasvir (MK-8408)
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-last of Ruzasvir (MK-8408)2.07 (1.60 to 2.67)1.32 (1.03 to 1.71)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-last in moderate ri/healthy: 1.56 · 90% CI 1.19 to 2.05
PrimaryAUC0-∞ of Ruzasvir

AUC0-∞ is a measure of total exposure to ruzasvir in plasma from the start of dosing to infinity following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-∞ of Ruzasvir
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-∞ of Ruzasvir2.19 (1.71 to 2.81)1.40 (1.09 to 1.79)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-∞ in moderate ri/healthy: 1.57 · 90% CI 1.20 to 2.05
PrimaryAUC0-24 of Ruzasvir

AUC0-24 is a measure of total exposure to ruzasvir in plasma from dosing to 24 hours following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose
Reported as:
Geometric mean · uM*hr
AUC0-24 of Ruzasvir
uM*hrModerate RI ParticipantsHealthy Participants
AUC0-24 of Ruzasvir1.11 (0.872 to 1.42)0.744 (0.583 to 0.948)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of auc0-24 in moderate ri/healthy: 1.49 · 90% CI 1.13 to 1.98
PrimaryCmax of Ruzasvir

Cmax is the maximum amount of ruzasvir in plasma following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · nM
Cmax of Ruzasvir
nMModerate RI ParticipantsHealthy Participants
Cmax of Ruzasvir117 (88.9 to 154)80.9 (61.6 to 106)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of cmax in moderate ri/healthy: 1.44 · 90% CI 1.05 to 1.98
PrimaryC24 of Ruzasvir

C24 is the plasma concentration of ruzasvir 24 hours following oral administration of MK-3682B.

Time frame:
24 hours post-dose
Reported as:
Geometric mean · nM
C24 of Ruzasvir
nMModerate RI ParticipantsHealthy Participants
C24 of Ruzasvir23.9 (18.5 to 30.8)15.5 (12.0 to 20.0)
Statistical analysis
  • Moderate RI Participants vs Healthy Participants · Gmr of c24 in moderate ri/healthy: 1.54 · 90% CI 1.15 to 2.07
PrimaryTmax of Ruzasvir

Tmax is the time required to reach the maximum post-dose plasma concentration of ruzasvir following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Median · Hours
Tmax of Ruzasvir
HoursModerate RI ParticipantsHealthy Participants
Tmax of Ruzasvir3.00 (1.50 to 4.00)3.00 (2.00 to 4.00)
PrimaryCL/F of Ruzasvir

CL/F is the apparent total body clearance of ruzasvir following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · Liters/hour
CL/F of Ruzasvir
Liters/hourModerate RI ParticipantsHealthy Participants
CL/F of Ruzasvir31.0 ± 34.548.8 ± 31.2
PrimaryVz/F of Ruzasvir

Vz/F is the apparent volume of distribution of ruzasvir following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · Liters
Vz/F of Ruzasvir
LitersModerate RI ParticipantsHealthy Participants
Vz/F of Ruzasvir1410 ± 40.02060 ± 26.9
Primaryt½ of Ruzasvir

t1/2 is the amount of time required to clear 50% of ruzasvir from plasma following oral administration of MK-3682B.

Time frame:
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose
Reported as:
Geometric mean · Hours
t½ of Ruzasvir
HoursModerate RI ParticipantsHealthy Participants
t½ of Ruzasvir31.50 ± 11.429.31 ± 7.0

Adverse events

Collected over Up to 14 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Moderate RI Participants0/8 (0%)0/8 (0%)2/8 (25%)
Healthy Participants0/8 (0%)0/8 (0%)1/8 (12.5%)
Most frequent other events
Most frequent other events
EventModerate RI ParticipantsHealthy Participants
HeadacheNervous system disorders2/80/8
NauseaGastrointestinal disorders1/80/8
VomitingGastrointestinal disorders1/81/8

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Moderate RI ParticipantsHealthy ParticipantsTotal
Mean69.6 ± 9.065.8 ± 2.667.7 ± 6.7
Sex: Female, Male
Sex: Female, Male(Participants)Moderate RI ParticipantsHealthy ParticipantsTotal
Female224
Male6612
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Moderate RI ParticipantsHealthy ParticipantsTotal
Mean30.32 ± 4.02330.11 ± 2.05730.22 ± 3.088
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02661126
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jan 22, 2016
Start date
Jan 19, 2016
Primary completion
Aug 26, 2016
Completion
Aug 26, 2016
Results posted
Dec 14, 2018
Last update
Jan 9, 2019

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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