A Study of the Pharmacokinetics and Safety of BMS-663068 Administered in Subjects With Normal Renal Function and With Mild, Moderate, Severe and End Stage Renal Dysfunction (ESRD)

Completed · Phase 1

Conditions studied: HIV Infections

In brief

An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.

Key facts

Study ID

NCT02674581

Run by

ViiV Healthcare

People needed

30

Starts

2016-02-26

Expected to finish

2016-05-24

Last updated by the study team

2018-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
• Evidence of rapidly deteriorating renal function, defined as a screening eGFR that has decreased from a previous eGFR by ≥ 50% within the last 3 months
• Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery (including cholecystectomy) that could impact the absorption of study drug
• Any major surgery within 4 weeks of study drug administration.
• Other protocol defined exclusion criteria could apply

Where it is running

• GSK Investigational Site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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