Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus Drug: BMS-663068 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
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
Actual Study Start Date : January 29, 2015
Actual Primary Completion Date : October 3, 2015
Actual Study Completion Date : October 3, 2015

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite). [ Time Frame: 5 days ]
  2. 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 ]
  3. 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 :
  1. 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.

  2. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467335


Locations
Layout table for location information
United States, New Jersey
GSK Investigational Site
Hamilton, New Jersey, United States, 08690
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials ViiV Healthcare
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02467335    
Other Study ID Numbers: 206280
AI438-053 ( Other Identifier: Bristol-Myers Squibb )
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases