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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
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infection, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
May 20, 2015
Last Updated
September 20, 2017
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
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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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