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

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ViiV Healthcare

Status and phase

Completed
Phase 1

Conditions

Infection, Human Immunodeficiency Virus

Treatments

Drug: BMS-663068

Study type

Interventional

Funder types

Industry

Identifiers

NCT02467335
AI438-053 (Other Identifier)
206280

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts 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

Trial design

52 participants in 4 patient groups

Healthy Subjects
Active Comparator group
Description:
Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1.
Treatment:
Drug: BMS-663068
Hepatic Impaired Subjects - Mild Rating
Active Comparator group
Description:
Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Treatment:
Drug: BMS-663068
Hepatic Impaired Subjects - Moderate Rating
Active Comparator group
Description:
Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Treatment:
Drug: BMS-663068
Hepatic Impaired Subjects - Severe Rating
Active Comparator group
Description:
Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Treatment:
Drug: BMS-663068

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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