Healthy ParticipantsPhase 1NCT03712540
An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants
A Phase 1 study testing BMS-986278 and Rifampin in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of experimental medication BMS-986278 given with the antibiotic Rifampin in 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 and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2018to 8 Nov 2018
- 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
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening
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
- History of significant cardiovascular disease
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Drug-Drug Interaction Study to Assess the Effect of Rifampin on the Pharmacokinetics of an Oral Dose of BMS-986278 in Healthy Participants
The purpose of this study is to investigate the effects of experimental medication BMS-986278 given with the antibiotic Rifampin in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986278, Rifampin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986278Drug
Oral administration 30 mg
RifampinDrug
Oral administration 600 mg
| Study group | Role | What they receive |
|---|---|---|
| BMS-986278 + Rifampin | Experimental | Treatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278 Receives: Drug: BMS-986278; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) for BMS-986278
Measured: Day 1 and 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for BMS-986278
Measured: Up to 24 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278
Measured: Day 1 and 8
Terminal phase half-life (T-HALF) for BMS-986278
Measured: Day 1 and 8
Secondary outcomes (8)
Incidence of non-serious adverse events (AE)
Measured: Up to 24 days
Incidence of serious adverse events (SAE)
Measured: Up to 24 days
Incidence of AE leading to discontinuation
Measured: Up to 24 days
Incidence of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests
Measured: Up to 24 days
Maximum observed plasma concentration (Cmax) for Rifampin
Measured: Day 8
Time of maximum observed plasma concentration (Tmax) for Rifampin
Measured: Day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for Rifampin
Measured: Day 8-9
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for Rifampin
Measured: Day 8-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start6 Sep 2018
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 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
- NCT03712540
- Sponsor's protocol ID
- IM027-017
- Status last verified
- Jun 2019
- First submitted
- 17 Oct 2018
- Last updated
- 12 Jun 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Drug-Drug Interaction Study to Assess the Effect of Rifampin on the Pharmacokinetics of an Oral Dose of BMS-986278 in Healthy Participants
- ClinicalTrials.gov ID
- NCT03712540
- Acronym / sponsor ID
- IM027-017
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 19 Oct 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 the effects of experimental medication BMS-986278 given with the antibiotic Rifampin in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986278 + Rifampin | Experimental | Drug: BMS-986278, Drug: RifampinTreatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening
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
- History of significant cardiovascular disease
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
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-986278Oral administration 30 mg | Drug | BMS-986278 + Rifampin |
| RifampinOral administration 600 mg | Drug | BMS-986278 + Rifampin |
Primary outcome
Maximum observed plasma concentration (Cmax) for BMS-986278
Time frame: Day 1 and 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for BMS-986278
Time frame: Up to 24 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278
Time frame: Day 1 and 8
Terminal phase half-life (T-HALF) for BMS-986278
Time frame: Day 1 and 8
8 secondary outcomes
Incidence of non-serious adverse events (AE)
Time frame: Up to 24 days
Incidence of serious adverse events (SAE)
Time frame: Up to 24 days
Incidence of AE leading to discontinuation
Time frame: Up to 24 days
Incidence of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests
Time frame: Up to 24 days
Maximum observed plasma concentration (Cmax) for Rifampin
Time frame: Day 8
Time of maximum observed plasma concentration (Tmax) for Rifampin
Time frame: Day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for Rifampin
Time frame: Day 8-9
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for Rifampin
Time frame: Day 8-9
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 12 Jun 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
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-986278 and Rifampin in people with Healthy Participants, 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 1 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 12 Jun 2019. 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. 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?
Maximum observed plasma concentration (Cmax) for BMS-986278 (time frame: Day 1 and 8). The study lists 4 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 12 Jun 2019.