Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
Primary Purpose
Infection, Human Immunodeficiency Virus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-663068
Sponsored by
About this trial
This is an interventional basic science trial for Infection, Human Immunodeficiency Virus
Eligibility 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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Healthy Subjects
Hepatic Impaired Subjects - Mild Rating
Hepatic Impaired Subjects - Moderate Rating
Hepatic Impaired Subjects - Severe Rating
Arm Description
Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1.
Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Outcomes
Primary Outcome Measures
The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite).
The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (INF) of BMS-626529 (metabolite).
The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (0-T) of BMS-626529 (metabolite).
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.
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.
Full Information
NCT ID
NCT02467335
First Posted
May 20, 2015
Last Updated
September 20, 2017
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT02467335
Brief Title
Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
Official Title
Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 29, 2015 (Actual)
Primary Completion Date
October 3, 2015 (Actual)
Study Completion Date
October 3, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Subjects
Arm Type
Active Comparator
Arm Description
Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1.
Arm Title
Hepatic Impaired Subjects - Mild Rating
Arm Type
Active Comparator
Arm Description
Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Arm Title
Hepatic Impaired Subjects - Moderate Rating
Arm Type
Active Comparator
Arm Description
Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Arm Title
Hepatic Impaired Subjects - Severe Rating
Arm Type
Active Comparator
Arm Description
Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Intervention Type
Drug
Intervention Name(s)
BMS-663068
Intervention Description
BMS-663068
Primary Outcome Measure Information:
Title
The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite).
Time Frame
5 days
Title
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
Title
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 Measure Information:
Title
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.
Description
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.
Time Frame
5 days
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
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