Clinical Trials

MainTitle

Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects

This study has been completed
Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02467335

First received: May 20, 2015
Last updated: September 20, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

A single oral dose study in subjects with hepatic impairment and healthy control subjects. Subjects will stay at the clinical facility where interval blood samplings will be obtained and examined for drug effect.

Condition Intervention Phase
Infection, Human Immunodeficiency Virus

Drug : BMS-663068
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite). [ Time Frame: 5 days ]
  • The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (INF) of BMS-626529 (metabolite). [ Time Frame: 5 days ]
  • The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (0-T) of BMS-626529 (metabolite). [ Time Frame: 5 days ]
Secondary Outcome Measures:
  • The safety and tolerability of a 600-mg single dose of BMS-663068 in subjects with hepatic impairment and in healthy subjects through analysis of adverse events. [ Time Frame: 5 days ]
    Adverse events will be arranged by system organ class, preferred term and hepatic function group. In addition, electrocardiogram readings will be summarized by time point relative to hepatic function group, and investigator-identified abnormalities, if present, will be listed.
  • The relationship between the Child-Pugh classification (including its components) as well as liver function tests and BMS-626529 profile PK parameters. [ Time Frame: 5 days ]

Enrollment: 52
Study Start Date: January 29, 2015
Study Completion Date: October 3, 2015
Primary Completion Date: October 3, 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Healthy Subjects
Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1.
Drug: BMS-663068

BMS-663068

Active Comparator: Hepatic Impaired Subjects - Mild Rating
Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Drug: BMS-663068

BMS-663068

Active Comparator: Hepatic Impaired Subjects - Moderate Rating
Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Drug: BMS-663068

BMS-663068

Active Comparator: Hepatic Impaired Subjects - Severe Rating
Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Drug: BMS-663068

BMS-663068

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 70 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

  • Males and females, ages 18 to 70 years, inclusive
  • BMI: 18.5 to 38 kg/m2
  • Body weight great or equal to 45.5 kg
  • Subjects with hepatic impairment
  • Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
  • Healthy subjects to the extent possible matched to the first four subjects with hepatic impairment with regard to age, body weight, and sex, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations


Exclusion Criteria:
  • Any major surgery within 4 weeks of study drug administration
  • Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
  • Subject has required additional medication for hepatic encephalopathy within 12 months (6 months for severe hepatic impairment) prior to dosing
  • Presence of severe ascites or edema in subjects, as judged by the PI

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: NCT02467335

Locations

United States, New Jersey
GSK Investigational Site
Hamilton, New Jersey, United States, 08690

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: NCT02467335   History of Changes  
Other Study ID Numbers: 206280  
  AI438-053  
Study First Received: May 20, 2015  
Last Updated: September 20, 2017  

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.