Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
Information provided by (Responsible Party)
First received: May 20, 2015
Last updated: September 20, 2017
Last Verified: September 2017
History of Changes
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.
Infection, Human Immunodeficiency Virus
Drug : BMS-663068
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 ]
- 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 ]
|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)|
Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1.
Hepatic Impaired Subjects - Mild Rating
Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Hepatic Impaired Subjects - Moderate Rating
Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Hepatic Impaired Subjects - Severe Rating
Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
|Ages Eligible for Study:||18 Years to 70 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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 LocationsChoosing 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 Show More
|United States, New Jersey|
|GSK Investigational Site|
|Hamilton, New Jersey, United States, 08690|
Sponsors and CollaboratorsViiV Healthcare
|Study Director:||GSK Clinical Trials||ViiV Healthcare|
|Responsible Party:||ViiV Healthcare|
|ClinicalTrials.gov Identifier:||NCT02467335 History of Changes|
|Other Study ID Numbers:||206280|
|Study First Received:||May 20, 2015|
|Last Updated:||September 20, 2017|
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on March 21, 2018
This information is provided by ClinicalTrials.gov.