Trial Outcomes & Findings for Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070) (NCT NCT01512693)
NCT ID: NCT01512693
Last Updated: 2018-08-29
Results Overview
For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.
COMPLETED
PHASE1
17 participants
Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
2018-08-29
Participant Flow
Participant milestones
| Measure |
Moderate Hepatic Insufficiency Group
Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
|
Healthy Matched Control Group
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Moderate Hepatic Insufficiency Group
Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
|
Healthy Matched Control Group
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)
Baseline characteristics by cohort
| Measure |
Moderate Hepatic Insufficiency Group
n=8 Participants
Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
|
Healthy Matched Control Group
n=9 Participants
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdosePopulation: The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.
For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.
Outcome measures
| Measure |
Moderate Hepatic Insufficiency Group
n=8 Participants
Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
|
Healthy Matched Control Group
n=8 Participants
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
|
|---|---|---|
|
Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose
|
28.84 μM*hr
Interval 21.88 to 38.01
|
33.79 μM*hr
Interval 25.64 to 44.54
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdosePopulation: The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.
For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.
Outcome measures
| Measure |
Moderate Hepatic Insufficiency Group
n=8 Participants
Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
|
Healthy Matched Control Group
n=8 Participants
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
|
|---|---|---|
|
Maximum Concentration (Cmax) of MK-0822 After Single Dose
|
199.41 nM
Interval 150.26 to 264.64
|
279.59 nM
Interval 210.68 to 371.05
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdosePopulation: The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.
For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.
Outcome measures
| Measure |
Moderate Hepatic Insufficiency Group
n=8 Participants
Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
|
Healthy Matched Control Group
n=8 Participants
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
|
|---|---|---|
|
Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose
|
4.00 hr
Interval 2.0 to 48.0
|
24.00 hr
Interval 2.0 to 48.0
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdosePopulation: The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.
Apparent terminal half-life is the time required to divide the plasma (serum) concentration by two after reaching pseudo-equilibrium. (Note: it is not the time required to eliminate half the administered dose.) For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2. Results are presented using harmonic mean and jackknife standard deviation.
Outcome measures
| Measure |
Moderate Hepatic Insufficiency Group
n=8 Participants
Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
|
Healthy Matched Control Group
n=8 Participants
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
|
|---|---|---|
|
Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose
|
91.5 hr
Standard Deviation 30.1
|
70.5 hr
Standard Deviation 10.2
|
Adverse Events
Moderate Hepatic Insufficiency Group
Healthy Matched Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moderate Hepatic Insufficiency Group
n=8 participants at risk
Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
|
Healthy Matched Control Group
n=9 participants at risk
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
|
|---|---|---|
|
Infections and infestations
Nasopharynigitis
|
12.5%
1/8 • Number of events 1 • Up to 15 days
The safety population consisted of all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Up to 15 days
The safety population consisted of all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Up to 15 days
The safety population consisted of all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Up to 15 days
The safety population consisted of all participants who received at least one dose of the study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60