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

NCT04303156 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-10-28

Study results available
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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

DRUG

Islatravir

Single oral dose of 60 mg Islatravir administered in capsule form

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2020-10-19
Completion
2020-10-19
FDA Drug
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04303156 on ClinicalTrials.gov