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Completed

NCT Number: NCT01732848

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

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

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Key information

Conditions

Healthy Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy and hepatitis C virus (HCV)-infected subjects who participated in prior Phase 1 trial with BMS-986094/INX-08189 and:
  • Received at least 1 dose of INX-08189 or
  • Received placebo in studies for HCV-infected subjects (INH-189-002 or INH-189-006)
  • Age 18 or older

Exclusion criteria

-

Treatment and study plan

BMS-986094/INX-08189

Drug

Other names: Observational study - No Intervention subjects were previously treated with BMS-986094/INX-08189

Placebo matching BMS-986094/INX-08189

Drug

Other names: Observational study - No Intervention subjects were previously treated with Placebo matching BMS-986094/INX-08189

Primary outcomes

  1. 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

    Time frame: Up to Day 90

  2. 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

    Time frame: Up to Day 90

Secondary outcomes

  1. 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)

    Time frame: Baseline (pre-dose Day 1 ECG from parent study) and By Day 30

  2. 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

    Time frame: By Day 90

  3. Abnormalities in B-type-natriuretic peptide (BNP) levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094

    Time frame: By Day 30

  4. 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

    Time frame: Baseline (Day 1 from parent study) and By Day 14

  5. Abnormalities in urinary albumin excretion that may be associated with prior exposure to single or multiple oral doses of BMS-986094

    Time frame: By Day 7

  6. 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

    Time frame: By Day 90

  7. 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

    Time frame: By Day 30

  8. Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094

    Time frame: By Day 30

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 26, 2012
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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