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

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467335
• Other study ID #: 206280
• Secondary ID: AI438-053
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2015
• Last updated: September 20, 2017
• Start date: January 29, 2015
• Est. completion date: October 3, 2015

Study information

• Verified date: September 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 3, 2015
• Est. primary completion date: October 3, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• BMS-663068
BMS-663068

Locations

Country	Name	City	State
United States	GSK Investigational Site	Hamilton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite).		5 days
Primary	The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (INF) of BMS-626529 (metabolite).		5 days
Primary	The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (0-T) of BMS-626529 (metabolite).		5 days
Secondary	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.	5 days
Secondary	The relationship between the Child-Pugh classification (including its components) as well as liver function tests and BMS-626529 profile PK parameters.		5 days