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)

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Oral BMS-663068 (pro-drug)

• Registration Number: NCT02674581
• Lead Sponsor: ViiV Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-04
• Study Start: 2016-02-26
• Primary Completion: 2016-05-24
• Study Completion: 2016-05-24
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
End Stage Renal Disease Subjects	Oral BMS-663068 (pro-drug)	A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Mild Renal Impairment Subjects	Oral BMS-663068 (pro-drug)	A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Moderate Renal Impairment Subjects	Oral BMS-663068 (pro-drug)	A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Severe Renal Impairment Subjects	Oral BMS-663068 (pro-drug)	A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Healthy Subjects	Oral BMS-663068 (pro-drug)	A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

Primary Outcome Measures

Name	Time	Method
Effect of Renal Impairment on The Primary Endpoints of Cmax	Day 1 - Day 5	To assess the effect of varying degrees of renal impairment on the exposure of BMS-626529 after a single oral-dose administration of the pro-drug, BMS-663068, will be evaluated by assessing the primary endpoints of Cmax, for BMS-626529.

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of ECGs, vital signs, physical examination, and clinical laboratory tests.	Day 1 - Day 5	To assess the safety and tolerability of BMS-663068 in subjects with normal renal function and subjects with impaired renal functions, will be measured by the following secondary endpoints: Incidence of AEs, Serious Adverse Events (SAEs), and AEs leading to discontinuation, and results of vital signs, ECGs, physical examination, and clinical laboratory tests.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Miami, Florida, United States