NCT04303156

Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Islatravir (MK-8591) in Subjects With Severe Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the general tolerability and pharmacokinetics (PK) of a single 60 mg dose of MK-8591 (Islatravir) in participants with severe renal insufficiency, compared to participants in good health.

Conditions

• Human Immunodeficiency Virus (HIV) Infection

Interventions

Type	Name	Description
DRUG	Islatravir	Single oral dose of 60 mg Islatravir administered in capsule form

Timeline

• Start date: 2020-06-18
• Primary completion: 2020-10-19
• Completion: 2020-10-19
• First posted: 2020-03-10
• Last updated: 2021-10-28
• Results posted: 2021-10-28

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study