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

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ClinicalTrials.gov Identifier: NCT02467335
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Tracking Information
First Submitted Date  ICMJE May 20, 2015
First Posted Date  ICMJE June 10, 2015
Last Update Posted Date September 25, 2017
Actual Study Start Date  ICMJE January 29, 2015
Actual Primary Completion Date October 3, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
Official Title  ICMJE Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Infection, Human Immunodeficiency Virus
Intervention  ICMJE Drug: BMS-663068
BMS-663068
Study Arms  ICMJE
  • Active Comparator: Healthy Subjects
    Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1.
    Intervention: Drug: BMS-663068
  • Active Comparator: Hepatic Impaired Subjects - Mild Rating
    Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
    Intervention: Drug: BMS-663068
  • Active Comparator: Hepatic Impaired Subjects - Moderate Rating
    Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
    Intervention: Drug: BMS-663068
  • Active Comparator: Hepatic Impaired Subjects - Severe Rating
    Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
    Intervention: Drug: BMS-663068
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2017)
52
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2015)
30
Actual Study Completion Date  ICMJE October 3, 2015
Actual Primary Completion Date October 3, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02467335
Other Study ID Numbers  ICMJE 206280
AI438-053 ( Other Identifier: Bristol-Myers Squibb )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ViiV Healthcare
Study Sponsor  ICMJE ViiV Healthcare
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials ViiV Healthcare
PRS Account ViiV Healthcare
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP