Trial Outcomes & Findings for Pharmacokinetics of Vaniprevir (MK-7009) and Hepatitis C Virus RNA Levels After Vaniprevir Treatment (MK-7009-029) (NCT NCT00954993)
NCT ID: NCT00954993
Last Updated: 2018-10-18
Results Overview
Participants were treated with vaniprevir twice daily on days 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were to be collected at 6, 12 and 24 hours postdose to determine the AUC of vaniprevir. AUC is the integrated area under the curve for plasma concentration of vaniprevir over time.
TERMINATED
PHASE1
3 participants
6, 12 and 24 hours postdose on day 4 of each period (up to Day 148)
2018-10-18
Participant Flow
Participant milestones
| Measure |
Vaniprevir 600 mg - 300 mg Arm
For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
|
|---|---|
|
Period 1
STARTED
|
3
|
|
Period 1
COMPLETED
|
3
|
|
Period 1
NOT COMPLETED
|
0
|
|
Washout
STARTED
|
3
|
|
Washout
COMPLETED
|
3
|
|
Washout
NOT COMPLETED
|
0
|
|
Period 2
STARTED
|
3
|
|
Period 2
COMPLETED
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Vaniprevir (MK-7009) and Hepatitis C Virus RNA Levels After Vaniprevir Treatment (MK-7009-029)
Baseline characteristics by cohort
| Measure |
Vaniprevir 600 mg - 300 mg Arm
n=3 Participants
For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
|
|---|---|
|
Age, Continuous
|
53 Years
STANDARD_DEVIATION 8.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6, 12 and 24 hours postdose on day 4 of each period (up to Day 148)Population: Since only a single liver sample timepoint at either 6 or 12 hours was obtained from each participant, and no 24 hour timepoint was collected from any participant due to the early termination of the study, the AUC (0-12 hrs) was not calculated
Participants were treated with vaniprevir twice daily on days 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were to be collected at 6, 12 and 24 hours postdose to determine the AUC of vaniprevir. AUC is the integrated area under the curve for plasma concentration of vaniprevir over time.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6, 12 and 24 hours postdose on day 4 of each period (up to day 148)Population: Participants treated with vaniprevir who had a liver biopsy were analyzed as two separate groups that received 600 mg and 300 mg doses . No biopsies were collected at the 24 hour timepoint.
Participants were treated with vaniprevir on days, 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were collected at 6, 12, and 24 hours postdose to determine the concentration of vaniprevir in the liver.
Outcome measures
| Measure |
600 mg Dose of Vaniprevir
n=3 Participants
600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
|
300 mg Dose of Vaniprevir
n=3 Participants
300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
|
|---|---|---|
|
Concentration of Vaniprevir in the Liver
6 Hours (n=2)
|
169000 nM
Interval 79100.0 to 258000.0
|
84600 nM
Interval 67500.0 to 102000.0
|
|
Concentration of Vaniprevir in the Liver
12 Hours (n=1)
|
53700 nM
Interval 53700.0 to 53700.0
|
29400 nM
Interval 29400.0 to 29400.0
|
PRIMARY outcome
Timeframe: 6, 12 and 24 hours postdose on day 4 of each period (up to day 148)Population: Since only a single liver sample timepoint was obtained from each participant at either 6 or 12 hours, and the 24 hour timepoint was not collected from any participant due to the early termination of the study, the t-1/2 could not be determined.
Participants were treated with vaniprevir twice daily on days 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were to be collected at 6, 12 and 24 hours postdose to determine the t-1/2 of vaniprevir. The t-1/2 is the time taken to eliminate half the amount of vaniprevir.
Outcome measures
Outcome data not reported
Adverse Events
600 mg Dose of Vaniprevir
300 mg Dose of Vaniprevir
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
600 mg Dose of Vaniprevir
n=3 participants at risk
600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
|
300 mg Dose of Vaniprevir
n=3 participants at risk
300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
|
|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
33.3%
1/3 • Up to approximately Day 148
|
0.00%
0/3 • Up to approximately Day 148
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to approximately Day 148
|
33.3%
1/3 • Up to approximately Day 148
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Up to approximately Day 148
|
0.00%
0/3 • Up to approximately Day 148
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
33.3%
1/3 • Up to approximately Day 148
|
33.3%
1/3 • Up to approximately Day 148
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/3 • Up to approximately Day 148
|
33.3%
1/3 • Up to approximately Day 148
|
|
Psychiatric disorders
Anger
|
33.3%
1/3 • Up to approximately Day 148
|
0.00%
0/3 • Up to approximately Day 148
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER