Trial Outcomes & Findings for A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005) (NCT NCT01010906)

Results Overview

Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

0-48 hours postdose

Results posted on

2018-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Mild Hepatic Insufficiency (HI) Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir	Healthy Control for Mild HI Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir	Moderate HI Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir	Healthy Control for Moderate HI Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir	Severe HI Participants with severe HI administered a single 200 mg oral tablet of vaniprevir	Healthy Control for Severe HI Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
Overall Study STARTED	10	10	10	10	10	10
Overall Study COMPLETED	10	10	10	10	10	10
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mild Hepatic Insufficiency (HI) n=10 Participants Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir	Healthy Control for Mild HI n=10 Participants Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir	Moderate HI n=10 Participants Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir	Healthy Control for Moderate HI n=10 Participants Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir	Severe HI n=10 Participants Participants with severe HI administered a single 200 mg oral tablet of vaniprevir	Healthy Control for Severe HI n=10 Participants Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir	Total n=60 Participants Total of all reporting groups
Age, Continuous	50.3 Years STANDARD_DEVIATION 5.03 • n=5 Participants	52.1 Years STANDARD_DEVIATION 3.54 • n=7 Participants	52.1 Years STANDARD_DEVIATION 6.51 • n=5 Participants	53.3 Years STANDARD_DEVIATION 4.90 • n=4 Participants	53.4 Years STANDARD_DEVIATION 6.08 • n=21 Participants	52.6 Years STANDARD_DEVIATION 7.04 • n=8 Participants	52.3 Years STANDARD_DEVIATION 5.49 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	14 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	46 Participants n=8 Participants

PRIMARY outcome

Timeframe: 0-48 hours postdose

Population: Participants administered at least one dose of investigational drug. AUC for one participant with Mild HI was not estimated due to poor correlation of the linear regression.

Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.

Outcome measures

Outcome measures
Measure	Mild Hepatic Insufficiency (HI) n=9 Participants Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir	Healthy Control for Mild HI n=10 Participants Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir	Moderate HI n=10 Participants Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir	Healthy Control for Moderate HI n=10 Participants Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir	Severe HI n=10 Participants Participants with severe HI administered a single 200 mg oral tablet of vaniprevir	Healthy Control for Severe HI n=10 Participants Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration	2.68 µM.hr Interval 1.39 to 5.18	1.48 µM.hr Interval 0.84 to 2.59	5.09 µM.hr Interval 2.21 to 11.7	1.64 µM.hr Interval 0.67 to 3.98	7.79 µM.hr Interval 5.03 to 12.0	0.925 µM.hr Interval 0.61 to 1.41

SECONDARY outcome

Timeframe: 0-48 hours postdose

Population: Participants administered at least one dose of investigational drug.

Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The Cmax of vaniprevir in blood plasma was based on an ANCOVA model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.