HealthyPhase 1NCT02293629
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects
A Phase 1 study testing BMS-986147 in people with Healthy, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BMS-986147
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women, ages 18 to 45 years
- Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory evaluations
- Women of child bearing potential are eligible for enrollment.
- Women must have a negative pregnancy test
Who cannot join
- Evidence of organ dysfunction
- Any significant acute or chronic medical illness
- Inability to: tolerate oral medications, be venipunctured
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects
This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients.
- Conditions
- Healthy
- Being tested
- BMS-986147, Placebo matching BMS-986147
- Keywords
- Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986147Drug
Placebo matching BMS-986147Drug
| Study group | Role | What they receive |
|---|---|---|
| A1: BMS-986147 or Placebo matching BMS-986147 | Placebo comparator | Single oral dose as specified Receives: Drug: BMS-986147; Drug: Placebo matching BMS-986147 |
| A2: BMS-986147 or Placebo matching BMS-986147 | Placebo comparator | Single oral dose as specified Receives: Drug: BMS-986147; Drug: Placebo matching BMS-986147 |
| A3: BMS-986147 or Placebo matching BMS-986147 | Placebo comparator | Single oral dose as specified Receives: Drug: BMS-986147; Drug: Placebo matching BMS-986147 |
| B1: BMS-986147 or Placebo matching BMS-986147 | Active comparator | Daily oral dose as specified Receives: Drug: BMS-986147; Drug: Placebo matching BMS-986147 |
| B2: BMS-986147 or Placebo matching BMS-986147 | Active comparator | Daily oral dose as specified Receives: Drug: BMS-986147; Drug: Placebo matching BMS-986147 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations
Adverse event (AE)
Measured: Up to 30 days post last dose of study drug
Safety and tolerability of multiple oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations
Measured: Up to 30 days post last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionNov 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 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
- NCT02293629
- Sponsor's protocol ID
- IM008-003
- Status last verified
- May 2015
- First submitted
- 14 Nov 2014
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02293629
- Acronym / sponsor ID
- IM008-003
- Conditions
- Healthy
- Keywords
- Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Nov 2014 (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.
This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A1: BMS-986147 or Placebo matching BMS-986147 | Placebo comparator | Drug: BMS-986147, Drug: Placebo matching BMS-986147Single oral dose as specified |
| A2: BMS-986147 or Placebo matching BMS-986147 | Placebo comparator | Drug: BMS-986147, Drug: Placebo matching BMS-986147Single oral dose as specified |
| A3: BMS-986147 or Placebo matching BMS-986147 | Placebo comparator | Drug: BMS-986147, Drug: Placebo matching BMS-986147Single oral dose as specified |
| B1: BMS-986147 or Placebo matching BMS-986147 | Active comparator | Drug: BMS-986147, Drug: Placebo matching BMS-986147Daily oral dose as specified |
| B2: BMS-986147 or Placebo matching BMS-986147 | Active comparator | Drug: BMS-986147, Drug: Placebo matching BMS-986147Daily oral dose as specified |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women, ages 18 to 45 years
- Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory evaluations
- Women of child bearing potential are eligible for enrollment.
- Women must have a negative pregnancy test
Key exclusion criteria (3 listed)
- Evidence of organ dysfunction
- Any significant acute or chronic medical illness
- Inability to: tolerate oral medications, be venipunctured
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-986147 | Drug | A1: BMS-986147 or Placebo matching BMS-986147, A2: BMS-986147 or Placebo matching BMS-986147, A3: BMS-986147 or Placebo matching BMS-986147, B1: BMS-986147 or Placebo matching BMS-986147, B2: BMS-986147 or Placebo matching BMS-986147 |
| Placebo matching BMS-986147 | Drug | A1: BMS-986147 or Placebo matching BMS-986147, A2: BMS-986147 or Placebo matching BMS-986147, A3: BMS-986147 or Placebo matching BMS-986147, B1: BMS-986147 or Placebo matching BMS-986147, B2: BMS-986147 or Placebo matching BMS-986147 |
Primary outcome
Safety and tolerability of single oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations
Time frame: Up to 30 days post last dose of study drug
Adverse event (AE)
Safety and tolerability of multiple oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations
Time frame: Up to 30 days post last dose of study drug
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 19 May 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986147 in people with Healthy, run by Bristol-Myers Squibb at 1 site in United States.
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 3 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 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 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?
Safety and tolerability of single oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations (time frame: Up to 30 days post last dose of study drug). 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 19 May 2015.