A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Healthy; Hepatitis C

Treatments: Drug: Placebo matching BMS-986094/INX-08189; Drug: BMS-986094/INX-08189

Study type: Observational

Funder types: Industry

Identifiers

NCT01732848

AI472-013

Details and patient eligibility

About

The purpose of this study is to determine the rate of kidney or heart impairment, if any, in subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy and hepatitis C virus (HCV)-infected subjects who participated in prior Phase 1 trial with BMS-986094/INX-08189 and:

  1. Received at least 1 dose of INX-08189 or
  2. Received placebo in studies for HCV-infected subjects (INH-189-002 or INH-189-006)

• Age 18 or older

Exclusion criteria

Trial design

113 participants in 2 patient groups

Subjects treated with BMS-986094/INX-08189

Description:

Subjects who participated in a clinical trial in which at least 1 dose of BMS-986094/INX-08189 was administered

Treatment:

Drug: BMS-986094/INX-08189

Subjects treated with Placebo matching BMS-986094/INX-08189

Description:

Subjects who participated in a clinical trial in which at least 1 dose of Placebo matching BMS-986094/INX-08189 was administered

Treatment:

Drug: Placebo matching BMS-986094/INX-08189