Hepatic ImpairmentPhase 1NCT05386589
A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)
A Phase 1 study testing Molnupiravir in people with Hepatic Impairment, run by Merck Sharp & Dohme LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Molnupiravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jun 2022to 5 Jan 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Centers of America ( Hollywood ) ( Site 0002)
Hollywood, Florida, 33024
Clinical Pharmacology of Miami ( Site 0003)
Miami, Florida, 33014
Thomas Jefferson University - Pharmacology and Experimental Therapeutics ( Site 0001)
Philadelphia, Pennsylvania, 19107
About this study
Official title: An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment
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.
- Conditions
- Hepatic Impairment
- Being tested
- Molnupiravir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MolnupiravirDrug
Also called MK-4482,, MOV, EIDD-2801
Four 200 mg capsules administered orally as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment received a single oral dose of molnupiravir 800 mg on Day 1. Receives: Drug: Molnupiravir |
| Healthy-Matched Control Group | Experimental | Healthy matched participants received a single oral dose of molnupiravir 800 mg on Day 1. Receives: Drug: Molnupiravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC)
The plasma AUC0-∞ of NHC is reported.
Measured: Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose
Maximum Plasma Concentration (Cmax) of NHC
The plasma Cmax of NHC is reported.
Measured: Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose
Secondary outcomes (1)
Number of Participants Experiencing ≥1 Adverse Event (AE)
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.
Measured: Up to ~ 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start14 Jun 2022
- Primary completion18 Dec 2022
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386589
- Sponsor's protocol ID
- 4482-016
- Other IDs
- MK-4482-016
- Status last verified
- Jan 2025
- First submitted
- 18 May 2022
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Duncan KE, Carstens RP, Butterfield KL, Jin Y, Inbody LR, Schaeffer AK, Matthews CZ, Zhao T, Patel S, Maas BM, Cheng MH, Stoch SA. Assessment of pharmacokinetics and tolerability following single-dose administration of molnupiravir in participants with hepatic or renal impairment. Clin Transl Sci. 2024 Dec;17(12):e70073. doi: 10.1111/cts.70073.
PubMed 39601078
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment
- ClinicalTrials.gov ID
- NCT05386589
- Acronym / sponsor ID
- 4482-016
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Posted 9 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Drug: MolnupiravirParticipants with moderate hepatic impairment received a single oral dose of molnupiravir 800 mg on Day 1. |
| Healthy-Matched Control Group | Experimental | Drug: MolnupiravirHealthy matched participants received a single oral dose of molnupiravir 800 mg on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MolnupiravirAlso: MK-4482,, MOV, EIDD-2801Four 200 mg capsules administered orally as a single dose | Drug | Healthy-Matched Control Group, Moderate Hepatic Impairment |
Primary outcome
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC)
Time frame: Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose
The plasma AUC0-∞ of NHC is reported.
Maximum Plasma Concentration (Cmax) of NHC
Time frame: Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose
The plasma Cmax of NHC is reported.
1 secondary outcome
Number of Participants Experiencing ≥1 Adverse Event (AE)
Time frame: Up to ~ 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39601078Duncan KE, Carstens RP, Butterfield KL, Jin Y, Inbody LR, Schaeffer AK, Matthews CZ, Zhao T, Patel S, Maas BM, Cheng MH, Stoch SA. Assessment of pharmacokinetics and tolerability following single-dose administration of molnupiravir in participants with hepatic or renal impairment. Clin Transl Sci. 2024 Dec;17(12):e70073. doi: 10.1111/cts.70073.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Molnupiravir in people with Hepatic Impairment, run by Merck Sharp & Dohme LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC) (time frame: Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05386589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.