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)

An Open-label Study to Evaluate the Pharmacokinetics and Safety of BMS-663068 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-Stage Renal Dysfunction

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

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Oral BMS-663068 (pro-drug)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Renal Impairment on The Primary Endpoints of Cmax	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.	Day 1 - Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 1 - Day 5

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2016
• Primary Completion (Actual): May 24, 2016
• Study Completion (Actual): May 24, 2016

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Fostemsavir
• Other Study ID Numbers: 206217; AI438-070 (Other Identifier: Bristol-Myers Squibb)