Clinical trial NCT01732848: A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)
Official title: A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Hepatitis C
Keywords: Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-11-26
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who participated in prior trial with BMS-986094/INX-08189 and received at least 1 dose of INX-08189 or placebo in trials INH-189-002 or INH-189-006

Brief summary: 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


Eligibility criteria: 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:

-

Primary outcomes:
measure: Rate of renal impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired renal function and require referral to a nephrologist
timeFrame: Up to Day 90
measure: Rate of cardiac impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired cardiac function and require referral to a cardiologist
timeFrame: Up to Day 90
Secondary outcomes:
measure: Changes in the electrocardiographic parameters observed in association with prior exposure to single and multiple oral doses of BMS-986094 compared to pre-exposure electrocardiograms (ECGs)
timeFrame: Baseline (pre-dose Day 1 ECG from parent study) and By Day 30
measure: Abnormalities in cardiac ejection fraction (EF) as determined by trans-thoracic echocardiogram that may be associated with prior exposure to single or multiple oral doses of BMS-986094
timeFrame: By Day 90
measure: Abnormalities in B-type-natriuretic peptide (BNP) levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094
timeFrame: By Day 30
measure: Changes in serum creatinine levels compared to pre-exposure levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094
timeFrame: Baseline (Day 1 from parent study) and By Day 14
measure: Abnormalities in urinary albumin excretion that may be associated with prior exposure to single or multiple oral doses of BMS-986094
timeFrame: By Day 7
measure: Presence of signs, symptoms or medical history suggestive of heart failure or renal failure that may have been observed since last exposure to BMS-986094
timeFrame: By Day 90
measure: Abnormalities in creatine phosphokinase (CPK) and creatine phosphokinase-metabolic (CPK-MB) levels that may be associated with prior exposure to single or multiple doses of BMS-986094
timeFrame: By Day 30
measure: Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094
timeFrame: By Day 30
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: St. Paul
country: United States
facility: Prism Research
state: Minnesota
city: Knoxville
country: United States
facility: New Orleans Center For Clinical Research - Knoxville
state: Tennessee
city: San Antonio
country: United States
facility: Local Institution
state: Texas
city: San Juan
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: