HealthyNCT01732848
A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)
An observational study of Healthy and Hepatitis C, run by Bristol-Myers Squibb at 5 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hepatitis C
- What is being tested?
- BMS-986094/INX-08189
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Nov 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
New Orleans Center For Clinical Research - Knoxville
Knoxville, Tennessee, 37920
Local Institution
Los Angeles, California, 90036
Prism Research
Saint Paul, Minnesota, 55114
Local Institution
San Antonio, Texas, 78215
About this study
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
- Conditions
- Healthy, Hepatitis C
- Being tested
- BMS-986094/INX-08189, Placebo matching BMS-986094/INX-08189
- Keywords
- Volunteers
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986094/INX-08189Drug
Also called Observational study - No Intervention subjects were previously treated with BMS-986094/INX-08189
Placebo matching BMS-986094/INX-08189Drug
Also called Observational study - No Intervention subjects were previously treated with Placebo matching BMS-986094/INX-08189
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with BMS-986094/INX-08189 | Subjects who participated in a clinical trial in which at least 1 dose of BMS-986094/INX-08189 was administered Receives: Drug: BMS-986094/INX-08189 | |
| Subjects treated with Placebo matching BMS-986094/INX-08189 | Subjects who participated in a clinical trial in which at least 1 dose of Placebo matching BMS-986094/INX-08189 was administered Receives: Drug: Placebo matching BMS-986094/INX-08189 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to Day 90
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
Measured: Up to Day 90
Secondary outcomes (8)
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)
Measured: Baseline (pre-dose Day 1 ECG from parent study) and By Day 30
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
Measured: By Day 90
Abnormalities in B-type-natriuretic peptide (BNP) levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094
Measured: By Day 30
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
Measured: Baseline (Day 1 from parent study) and By Day 14
Abnormalities in urinary albumin excretion that may be associated with prior exposure to single or multiple oral doses of BMS-986094
Measured: By Day 7
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
Measured: By Day 90
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
Measured: By Day 30
Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094
Measured: By Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732848
- Sponsor's protocol ID
- AI472-013
- Status last verified
- Aug 2014
- First submitted
- 20 Nov 2012
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)
- ClinicalTrials.gov ID
- NCT01732848
- Acronym / sponsor ID
- AI472-013
- Conditions
- Healthy, Hepatitis C
- Keywords
- Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with BMS-986094/INX-08189 | – | Drug: BMS-986094/INX-08189Subjects who participated in a clinical trial in which at least 1 dose of BMS-986094/INX-08189 was administered |
| Subjects treated with Placebo matching BMS-986094/INX-08189 | – | Drug: Placebo matching BMS-986094/INX-08189Subjects who participated in a clinical trial in which at least 1 dose of Placebo matching BMS-986094/INX-08189 was administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Healthy and hepatitis C virus (HCV)-infected subjects who participated in prior Phase 1 trial with BMS-986094/INX-08189 and:
- Age 18 or older
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986094/INX-08189Also: Observational study - No Intervention subjects were previously treated with BMS-986094/INX-08189 | Drug | Subjects treated with BMS-986094/INX-08189 |
| Placebo matching BMS-986094/INX-08189Also: Observational study - No Intervention subjects were previously treated with Placebo matching BMS-986094/INX-08189 | Drug | Subjects treated with Placebo matching BMS-986094/INX-08189 |
Primary outcome
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
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
8 secondary outcomes
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
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
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
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
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
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
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
Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094
Time frame: By Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Hepatitis C, run by Bristol-Myers Squibb at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.