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Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)

Primary Purpose

Hepatic Insufficiency

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Ulonivirine

About this trial

This is an interventional treatment trial for Hepatic Insufficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Panel A: Mild HI

Panel B: Moderate HI

Panel C: Healthy Controls

Arm Description

Participants with mild HI receive a single oral dose of ulonivirine 400 mg on Day 1.

Participants with moderate HI receive a single oral dose of ulonivirine 400 mg on Day 1.

Healthy matched control participants receive a single oral dose of ulonivirine 400 mg on Day 1.

Outcomes

Primary Outcome Measures

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.

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.

Maximum Plasma Concentration (Cmax) of Ulonivirine

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

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

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

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

The Vz/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05093972

First Posted

October 18, 2021

Last Updated

August 30, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT05093972

Brief Title

Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)

Official Title

An Open-Label, Single-Dose Clinical Study to Evaluate Pharmacokinetics of MK-8507 in Participants With Mild or Moderate Hepatic Impairment.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 29, 2024 (Anticipated)

Primary Completion Date

April 3, 2025 (Anticipated)

Study Completion Date

April 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 mild or moderate HI is similar to that of healthy control participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Panel A: Mild HI

Arm Type

Experimental

Arm Description

Participants with mild HI receive a single oral dose of ulonivirine 400 mg on Day 1.

Arm Title

Panel B: Moderate HI

Arm Type

Experimental

Arm Description

Participants with moderate HI receive a single oral dose of ulonivirine 400 mg on Day 1.

Arm Title

Panel C: Healthy Controls

Arm Type

Active Comparator

Arm Description

Healthy matched control participants receive a single oral dose of ulonivirine 400 mg on Day 1.

Intervention Type

Drug

Intervention Name(s)

Ulonivirine

Other Intervention Name(s)

MK-8507

Intervention Description

Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.

Primary Outcome Measure Information:

Title

Area Under the Plasma Concentration-Time Curve from Dosing to Infinity (AUC0-∞) of Ulonivirine

Description

The AUC0-∞ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.

Time Frame