HealthyPhase 1NCT03035734
Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants
A Phase 1 study testing BMS-986141 Form A Tablet, BMS-986141 Form B tablet (low dose) and BMS-986141 Form B tablet (high dose) in people with Healthy, run by Bristol-Myers Squibb.
Trial summary
Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BMS-986141 Form A Tablet, BMS-986141 Form B tablet (low dose) and BMS-986141 Form B tablet (high dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2017to 7 Feb 2017
- Phase
- Phase 1
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
- Body mass index 18.0 kg/m2 to 32.0 kg/m2
- females must be of non-childbearing potential
Who cannot join
- known bleeding or coagulation disorders
- acute or chronic medical illness
- history of nausea or chronic diarrhea that lasts over 4 weeks
- history of periodontal disease or gingivitis which required treatment
- other exclusion criteria may apply
About this study
Official title: A Randomized Study to Evaluate the Bioavailability of BMS-986141 From a Form B Tablet Formulation Relative to the Form A Reference Tablet in Healthy Participants
Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males.
- Conditions
- Healthy
- Being tested
- BMS-986141 Form A Tablet, BMS-986141 Form B tablet (low dose), BMS-986141 Form B tablet (high dose)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986141 Form A TabletDrug
tablet
BMS-986141 Form B tablet (low dose)Drug
tablet
BMS-986141 Form B tablet (high dose)Drug
tablet
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Single oral dose BMS-986141 Form A tablet under fasting conditions Receives: Drug: BMS-986141 Form A Tablet |
| B | Experimental | Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions Receives: Drug: BMS-986141 Form B tablet (low dose) |
| C | Experimental | Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions Receives: Drug: BMS-986141 Form B tablet (high dose) |
| D | Experimental | Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions Receives: Drug: BMS-986141 Form B tablet (high dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet
Measured: 4 weeks
Secondary outcomes (1)
Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start25 Jan 2017
- Primary completion7 Feb 2017
- Study completion7 Feb 2017
Why it stopped: Business objectives have changed
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT03035734
- Sponsor's protocol ID
- CV006-023
- Other IDs
- 2016-001031-13, 2016
- Status last verified
- Mar 2018
- First submitted
- 23 Dec 2016
- Last updated
- 23 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Bioavailability of BMS-986141 From a Form B Tablet Formulation Relative to the Form A Reference Tablet in Healthy Participants
- ClinicalTrials.gov ID
- NCT03035734
- Acronym / sponsor ID
- CV006-023
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 7 Feb 2017 (actual)
- First posted
- 30 Jan 2017 (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.
Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: BMS-986141 Form A TabletSingle oral dose BMS-986141 Form A tablet under fasting conditions |
| B | Experimental | Drug: BMS-986141 Form B tablet (low dose)Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions |
| C | Experimental | Drug: BMS-986141 Form B tablet (high dose)Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions |
| D | Experimental | Drug: BMS-986141 Form B tablet (high dose)Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
- Body mass index 18.0 kg/m2 to 32.0 kg/m2
- females must be of non-childbearing potential
Key exclusion criteria (5 listed)
- known bleeding or coagulation disorders
- acute or chronic medical illness
- history of nausea or chronic diarrhea that lasts over 4 weeks
- history of periodontal disease or gingivitis which required treatment
- other exclusion criteria may apply
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-986141 Form A Tablettablet | Drug | A |
| BMS-986141 Form B tablet (low dose)tablet | Drug | B |
| BMS-986141 Form B tablet (high dose)tablet | Drug | C, D |
Primary outcome
Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet
Time frame: 4 weeks
1 secondary outcome
Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986141 Form A Tablet, BMS-986141 Form B tablet (low dose) and BMS-986141 Form B tablet (high dose) in people with Healthy, run by Bristol-Myers Squibb.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet (time frame: 4 weeks). 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 23 Mar 2018.