Trial Outcomes & Findings for A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016) (NCT NCT05386589)
NCT ID: NCT05386589
Last Updated: 2025-01-28
Results Overview
The plasma AUC0-∞ of NHC is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose
Results posted on
2025-01-28
Participant Flow
This study was conducted at 3 sites in the United States.
Participant milestones
| Measure |
Moderate Hepatic Impairment
Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir.
|
Healthy-Matched Control Group
Healthy matched participants will receive a single oral 800mg dose of molnupiravir.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)
Baseline characteristics by cohort
| Measure |
Moderate Hepatic Impairment
n=7 Participants
Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir.
|
Healthy-Matched Control Group
n=7 Participants
Healthy matched participants will receive a single oral 800mg dose of molnupiravir.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdosePopulation: All participants are included.
The plasma AUC0-∞ of NHC is reported.
Outcome measures
| Measure |
Moderate Hepatic Impairment
n=7 Participants
Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir.
|
Healthy-Matched Control Group
n=7 Participants
Healthy matched participants will receive a single oral 800mg dose of molnupiravir.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC)
|
8930 hr*ng/mL
Interval 6560.0 to 12100.0
|
10900 hr*ng/mL
Interval 8510.0 to 14000.0
|
PRIMARY outcome
Timeframe: Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdosePopulation: All participants are included.
The plasma Cmax of NHC is reported.
Outcome measures
| Measure |
Moderate Hepatic Impairment
n=7 Participants
Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir.
|
Healthy-Matched Control Group
n=7 Participants
Healthy matched participants will receive a single oral 800mg dose of molnupiravir.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of NHC
|
3660 ng/mL
Interval 2730.0 to 4900.0
|
3790 ng/mL
Interval 3260.0 to 4420.0
|
SECONDARY outcome
Timeframe: Up to ~ 14 daysPopulation: All participants are included.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Moderate Hepatic Impairment
n=7 Participants
Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir.
|
Healthy-Matched Control Group
n=7 Participants
Healthy matched participants will receive a single oral 800mg dose of molnupiravir.
|
|---|---|---|
|
Number of Participants Experiencing ≥1 Adverse Event (AE)
|
0 Participants
|
1 Participants
|
Adverse Events
Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy-Matched Control Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moderate Hepatic Impairment
n=7 participants at risk
Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir.
|
Healthy-Matched Control Group
n=7 participants at risk
Healthy matched participants will receive a single oral 800mg dose of molnupiravir.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/7 • Up to ~14 days
All participants are included.
|
14.3%
1/7 • Up to ~14 days
All participants are included.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
- Publication restrictions are in place
Restriction type: OTHER