Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
Study Details
Study Description
Brief Summary
This double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MK-8527 Low Dose QM Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
Drug: MK-8527
MK-8527 capsule
|
| Experimental: MK-8527 Medium Dose QM Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
Drug: MK-8527
MK-8527 capsule
|
| Experimental: MK-8527 High Dose QM Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
Drug: MK-8527
MK-8527 capsule
|
| Placebo Comparator: Placebo to MK-8527 Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period. |
Drug: Placebo to MK-8527
Placebo capsule matched to MK-8527
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With ≥1 Adverse Event (AE) [Up to ~28 weeks]
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.
- Number of Participants Discontinuing From Study Therapy Due to AE [Up to ~20 weeks]
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.
Secondary Outcome Measures
- Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527 [Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose]
The AUC0-last of MK-8527 will be determined.
- Maximum Plasma Concentration (Cmax) of MK-8527 [Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose]
The Cmax of MK-8527 will be determined.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
-
Has low-risk of HIV infection
-
Males: if capable of producing sperm, the participant agrees to the following during the intervention period and for ≥8 weeks after the last dose of study intervention: abstains from penile-vaginal intercourse OR uses approved contraception unless confirmed to be azoospermic.
-
Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception or is abstinent from penile-vaginal intercourse
Exclusion Criteria:
-
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
-
Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid [RNA])
-
Prior use of MK-8527 or islatravir (MK-8591)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 8527-007