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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)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oral BMS-663068 (pro-drug)
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Healthy Subjects

Mild Renal Impairment Subjects

Moderate Renal Impairment Subjects

Severe Renal Impairment Subjects

End Stage Renal Disease Subjects

Arm Description

A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 21, 2015
Last Updated
May 9, 2018
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT02674581
Brief Title
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)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 26, 2016 (Actual)
Primary Completion Date
May 24, 2016 (Actual)
Study Completion Date
May 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Subjects
Arm Type
Experimental
Arm Description
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Arm Title
Mild Renal Impairment Subjects
Arm Type
Experimental
Arm Description
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Arm Title
Moderate Renal Impairment Subjects
Arm Type
Experimental
Arm Description
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Arm Title
Severe Renal Impairment Subjects
Arm Type
Experimental
Arm Description
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Arm Title
End Stage Renal Disease Subjects
Arm Type
Experimental
Arm Description
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Intervention Type
Drug
Intervention Name(s)
Oral BMS-663068 (pro-drug)
Intervention Description
Oral BMS-663068 (pro-drug), metabolized to active BMS-626529
Primary Outcome Measure Information:
Title
Effect of Renal Impairment on The Primary Endpoints of Cmax
Description
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.
Time Frame
Day 1 - Day 5
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Day 1 - Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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)

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