Hepatic InsufficiencyPhase 1NCT05093972
Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)
A Phase 1 study testing Ulonivirine in people with Hepatic Insufficiency, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI). It is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (AUC0-∞) in participants with… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- Ulonivirine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 22 Jan 2027to 29 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Mild and Moderate HI (Panels A and B):
- Has a diagnosis of chronic (>6 months), stable HI with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function)
- Healthy Controls (Panel C):
- Is in good health
- All Participants (Panels A to C):
- Has a body mass index (BMI) ≥18.5 and ≤40 kg/m^2, inclusive
- If male, uses contraception in accordance with local regulations
- If female, is not pregnant or breastfeeding and one of the following applies: 1) is not a woman of childbearing potential (WOCBP), or 2) is a WOCBP and is abstinent/uses acceptable contraception, has a negative highly sensitive pregnancy test within 24 hours of receiving study intervention, and provides medical/menstrual/recent sexual history for review by the investigator
Who cannot join
- Mild and Moderate HI (Panels A and B):
- Has a history of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study
- Is not in sufficient health
- Is institutionalized/mentally or legally incapacitated
- Is positive for human immunodeficiency virus (HIV)-1 or HIV-2
- Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start
Show all 17Show fewer
- Is taking medication for a chronic condition and has not been on a stable regimen for ≥ 1 month
- Healthy Controls (Panel C):
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Is mentally or legally incapacitated
- Is positive for hepatitis B virus surface antigen (HBsAg), hepatitis C antibodies, HIV-1, or HIV-2
- Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to first dose of study drug
- All Participants (Panel A to C):
- Has a history of cancer (malignancy)
- Has a history of significant multiple and/or severe allergies
- Has known hypersensitivity to the active substance or any of the excipients of the study drug
- Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to Screening
About this study
Official title: An Open-Label, Single-Dose Clinical Study to Evaluate Pharmacokinetics of MK-8507 in Participants With Mild or Moderate Hepatic Impairment.
The purpose of this study is to evaluate pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI). It is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (AUC0-∞) in participants with mild or moderate HI is similar to that of healthy control participants.
- Conditions
- Hepatic Insufficiency
- Being tested
- Ulonivirine
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlonivirineDrug
Also called MK-8507
Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Panel A: Mild HI | Experimental | Participants with mild HI receive a single oral dose of ulonivirine 400 mg on Day 1. Receives: Drug: Ulonivirine |
| Panel B: Moderate HI | Experimental | Participants with moderate HI receive a single oral dose of ulonivirine 400 mg on Day 1. Receives: Drug: Ulonivirine |
| Panel C: Healthy Controls | Active comparator | Healthy matched control participants receive a single oral dose of ulonivirine 400 mg on Day 1. Receives: Drug: Ulonivirine |
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 Dosing to Infinity (AUC0-∞) of Ulonivirine
The AUC0-∞ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Area Under the Plasma Concentration-Time Curve from Dosing to Last Measurable Concentration (AUC0-last) of Ulonivirine
The AUC0-last of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Maximum Plasma Concentration (Cmax) of Ulonivirine
The Cmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Time to Maximum Plasma Concentration (Tmax) of Ulonivirine
The Tmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Apparent Plasma Terminal Half-life (t½) of Ulonivirine
The t½ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Apparent Total Clearance from Plasma After Oral Administration (CL/F) of Ulonivirine
The CL/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Apparent Volume of Distribution during Terminal Phase (Vz/F) of Ulonivirine
The Vz/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Secondary outcomes (1)
Percentage of Participants with an 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 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start22 Jan 2027 (estimated)
- Primary completion29 Jun 2027 (estimated)
- Study completion29 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies 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
- 22 participants (estimated)
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
- NCT05093972
- Sponsor's protocol ID
- 8507-014
- Other IDs
- MK-8507-014
- Status last verified
- Jul 2026
- First submitted
- 18 Oct 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose Clinical Study to Evaluate Pharmacokinetics of MK-8507 in Participants With Mild or Moderate Hepatic Impairment.
- ClinicalTrials.gov ID
- NCT05093972
- Acronym / sponsor ID
- 8507-014
- Conditions
- Hepatic Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2027 (estimated)
- Primary completion
- 29 Jun 2027 (estimated)
- Study completion
- 29 Jun 2027 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
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 pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI). It is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (AUC0-∞) in participants with mild or moderate HI is similar to that of healthy control participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Panel A: Mild HI | Experimental | Drug: UlonivirineParticipants with mild HI receive a single oral dose of ulonivirine 400 mg on Day 1. |
| Panel B: Moderate HI | Experimental | Drug: UlonivirineParticipants with moderate HI receive a single oral dose of ulonivirine 400 mg on Day 1. |
| Panel C: Healthy Controls | Active comparator | Drug: UlonivirineHealthy matched control participants receive a single oral dose of ulonivirine 400 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 (8 listed)
- Has a diagnosis of chronic (>6 months), stable HI with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function)
- Is in good health
- Has a body mass index (BMI) ≥18.5 and ≤40 kg/m^2, inclusive
- If male, uses contraception in accordance with local regulations
- If female, is not pregnant or breastfeeding and one of the following applies: 1) is not a woman of childbearing potential (WOCBP), or 2) is a WOCBP and is abstinent/uses acceptable contraception, has a negative highly sensitive pregnancy test within 24 hours of receiving study intervention, and provides medical/menstrual/recent sexual history for review by the investigator
Key exclusion criteria (17 listed)
- Has a history of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study
- Is not in sufficient health
- Is institutionalized/mentally or legally incapacitated
- Is positive for human immunodeficiency virus (HIV)-1 or HIV-2
- Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start
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 |
|---|---|---|
| UlonivirineAlso: MK-8507Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth. | Drug | Panel A: Mild HI, Panel B: Moderate HI, Panel C: Healthy Controls |
Primary outcome
Area Under the Plasma Concentration-Time Curve from Dosing to Infinity (AUC0-∞) of Ulonivirine
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The AUC0-∞ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Area Under the Plasma Concentration-Time Curve from Dosing to Last Measurable Concentration (AUC0-last) of Ulonivirine
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The AUC0-last of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Maximum Plasma Concentration (Cmax) of Ulonivirine
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The Cmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time to Maximum Plasma Concentration (Tmax) of Ulonivirine
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The Tmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Apparent Plasma Terminal Half-life (t½) of Ulonivirine
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The t½ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Apparent Total Clearance from Plasma After Oral Administration (CL/F) of Ulonivirine
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The CL/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Apparent Volume of Distribution during Terminal Phase (Vz/F) of Ulonivirine
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The Vz/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
1 secondary outcome
Percentage of Participants with an Adverse Event (AE)
Time frame: Up to 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ulonivirine in people with Hepatic Insufficiency, run by Merck Sharp & Dohme LLC.
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 8 inclusion and 17 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: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 Dosing to Infinity (AUC0-∞) of Ulonivirine (time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.