Healthy ParticipantsPhase 1NCT03429933
A Study of Experimental Medication BMS-986278 Given to Healthy Participants
A Phase 1 study testing BMS-986278 in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites in 2 countries.
Trial summary
The purpose of this study is to investigate experimental medication BMS-986278 given to healthy participants. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986278
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Feb 2018to 2 Mar 2019
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be in good general health in the opinion of the investigator
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)2
- Body weight between 55 and 105 kg, inclusive, at screening
- Female participants must have documented proof that they are not of childbearing potential
- Participants in the Japanese cohorts must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
Who cannot join
- Women who are of childbearing potential or breastfeeding
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
- History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
- Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
- Any major surgery within 6 weeks of study drug administration
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study (Including Food Effect, pH Effect, and Japanese Bridging Study) of the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986278 Administration in Healthy Participants
The purpose of this study is to investigate experimental medication BMS-986278 given to healthy participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986278, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986278Drug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | BMS-986278 or placebo Receives: Drug: BMS-986278; Other: Placebo |
| Multiple Ascending Dose | Experimental | BMS-986278 or placebo Receives: Drug: BMS-986278; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation
Measured: Up to 30 days
Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start7 Feb 2018
- Primary completion2 Mar 2019
- Study completion2 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 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
- NCT03429933
- Sponsor's protocol ID
- IM027-009
- Other IDs
- 2017-004136-10, 2017
- Status last verified
- Sep 2019
- First submitted
- 5 Feb 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study (Including Food Effect, pH Effect, and Japanese Bridging Study) of the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986278 Administration in Healthy Participants
- ClinicalTrials.gov ID
- NCT03429933
- Acronym / sponsor ID
- IM027-009
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- 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 investigate experimental medication BMS-986278 given to healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Drug: BMS-986278, Other: PlaceboBMS-986278 or placebo |
| Multiple Ascending Dose | Experimental | Drug: BMS-986278, Other: PlaceboBMS-986278 or placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be in good general health in the opinion of the investigator
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)2
- Body weight between 55 and 105 kg, inclusive, at screening
- Female participants must have documented proof that they are not of childbearing potential
- Participants in the Japanese cohorts must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
Key exclusion criteria (6 listed)
- Women who are of childbearing potential or breastfeeding
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
- History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
- Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
- Any major surgery within 6 weeks of study drug administration
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-986278Specified dose on specified days | Drug | Multiple Ascending Dose, Single Ascending Dose |
| PlaceboSpecified dose on specified days | Other | Multiple Ascending Dose, Single Ascending Dose |
Primary outcome
Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation
Time frame: Up to 30 days
Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations
Time frame: Up to 30 days
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 1 Oct 2019.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986278 in people with Healthy Participants, run by Bristol-Myers Squibb at 2 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 5 inclusion and 6 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, United Kingdom. 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.
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?
Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation (time frame: Up to 30 days). 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 1 Oct 2019.