Phase 1
Completed N=14
A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)
Source: ClinicalTrials.gov NCT05386589 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC) — 8930; 10900 hr*ng/mL
Summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of N-hydroxycytidine (NHC) following a single oral dose of molnupiravir in participants 18 to 75 years (inclusive) with moderate hepatic impairment and healthy matched controls.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC) |
8930; 10900 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of NHC |
3660; 3790 | — |
| SECONDARY Number of Participants Experiencing ≥1 Adverse Event (AE) |
0; 1 | — |
Eligibility Criteria
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
- Has a BMI ≥18.5 and ≤35 kg/m2
- Diagnosis of chronic (>6 months) stable Hepatic Impairment (HI) with features of cirrhosis due to any etiology (Moderate HI arm only)
- Has a score on the Child-Pugh scale ranging from 7 to 9 (Moderate HI arm only)
- In good health (except for Moderate HI)
Exclusion Criteria
- Anticipated survival of <3 months (Moderate HI arm only)
- Received antiviral and/or immune modulating therapy (Moderate HI only) for Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) within 90 days prior to study start
- History of clinically significant abnormalities or diseases (Healthy matched arm only).
- History of cancer
- Major surgery and/or donated or lost 1 unit of blood
- Taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month (Moderate HI arm only) and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 8 hours after administration of the study drug.
Data sourced from ClinicalTrials.gov (NCT05386589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.