Clinical Trials

MainTitle

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)

This study has been completed
Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02674581

First received: December 21, 2015
Last updated: May 9, 2018
Last Verified: May 2018
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Infections

Drug : Oral BMS-663068 (pro-drug)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Effect of Renal Impairment on The Primary Endpoints of Cmax [ Time Frame: 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:
  • 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. [ Time Frame: 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.

Enrollment: 30
Study Start Date: February 26, 2016
Study Completion Date: May 24, 2016
Primary Completion Date: May 24, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02674581

Locations

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

Sponsors and Collaborators

ViiV Healthcare
GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02674581   History of Changes  
Other Study ID Numbers: 206217  
  AI438-070  
Study First Received: December 21, 2015  
Last Updated: May 9, 2018  

Additional relevant MeSH terms:
HIV Infections
Renal Insufficiency

ClinicalTrials.gov processed this data on December 14, 2018
This information is provided by ClinicalTrials.gov.