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)

• Status: Completed
• Trial end date: 2016-05-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ViiV Healthcare
• Collaborators: Covance; GlaxoSmithKline
• Treatments: Fostemsavir

Criteria

Inclusion Criteria (For renal impaired subjects):

• Classification by renal function based on eGFR

• Clinical, ECG, and laboratory findings consistent with renal dysfunction

• BMI of 18.0 to 38.0 kg/m2 inclusive

• Women of child bearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control

• Slightly different inclusion criteria are defined in the protocol for healthy subjects

Exclusion Criteria:

• 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