Healthy VolunteersPhase 1NCT05985590
A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants
A Phase 1 study testing BMS-986278 and Drospirenone/Ethinyl Estradiol in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in Canada.
Trial summary
The purpose of the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female participants. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986278 and Drospirenone/Ethinyl Estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 18 Aug 2023to 11 Dec 2023
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index between 18.0 and 32.0 kilograms/meter square (kg/m^2), inclusive.
- Body weight ≥ 45 kg.
- Healthy females, as determined by physical examination and clinical laboratory assessments (including chemistry, hematology, coagulation, and urinalysis) within the normal range at the screening visit and on Day -1, as applicable.
Who cannot join
- Any significant acute or chronic medical illness.
- Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed (12 months prior to screening).
- Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, especially eye issues, as determined by the investigator.
- Note: Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of Multiple Doses of BMS-986278 on the Pharmacokinetics of Combined Oral Contraceptives (Drospirenone/Ethinyl Estradiol) in Healthy Female Participants
The purpose of the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female participants.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986278, Drospirenone/Ethinyl Estradiol
- Keywords
- Pharmacokinetics, BMS-986278, Hormonal contraceptives, Ethinyl estradiol, Drospirenone, Pulmonary fibrosis
- Medical subject headings
- Pulmonary Fibrosis
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
Drospirenone/Ethinyl EstradiolDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: DRSP/EE | Experimental | Not described Receives: Drug: Drospirenone/Ethinyl Estradiol |
| Treatment B: BMS-986278/DRSP/EE | Experimental | Not described Receives: Drug: BMS-986278; Drug: Drospirenone/Ethinyl Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Measured: Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
Measured: Predose and post-dose up to Day 28
Secondary outcomes (10)
Time of maximum observed concentration (Tmax)
Measured: Predose and post-dose up to Day 28
Terminal half-life (T-Half)
Measured: Predose and post-dose up to Day 28
Apparent total body clearance after extravascular administration (CL/F)
Measured: Predose and post-dose up to Day 28
Number of Participants with Adverse Events (AEs)
Measured: Up to Day 53
Number of Participants with Serious AEs (SAEs)
Measured: Up to Day 53
Number of Participants with AEs leading to discontinuation
Measured: Up to Day 53
Number of Participants with Physical Examination Abnormalities
Measured: Up to Day 28
Number of Participants with Vital Sign Abnormalities
Measured: Up to Day 28
Number of Participants with Electrocardiogram (ECG) Abnormalities
Measured: Up to Day 28
Number of Participants with Clinical Laboratory Abnormalities
Measured: Up to Day 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start18 Aug 2023
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT05985590
- Sponsor's protocol ID
- IM027-1013
- Status last verified
- Jan 2024
- First submitted
- 3 Aug 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of Multiple Doses of BMS-986278 on the Pharmacokinetics of Combined Oral Contraceptives (Drospirenone/Ethinyl Estradiol) in Healthy Female Participants
- ClinicalTrials.gov ID
- NCT05985590
- Acronym / sponsor ID
- IM027-1013
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, BMS-986278, Hormonal contraceptives, Ethinyl estradiol, Drospirenone, Pulmonary fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 14 Aug 2023 (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 the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: DRSP/EE | Experimental | Drug: Drospirenone/Ethinyl Estradiol |
| Treatment B: BMS-986278/DRSP/EE | Experimental | Drug: BMS-986278, Drug: Drospirenone/Ethinyl Estradiol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index between 18.0 and 32.0 kilograms/meter square (kg/m^2), inclusive.
- Body weight ≥ 45 kg.
- Healthy females, as determined by physical examination and clinical laboratory assessments (including chemistry, hematology, coagulation, and urinalysis) within the normal range at the screening visit and on Day -1, as applicable.
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness.
- Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed (12 months prior to screening).
- Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, especially eye issues, as determined by the investigator.
- Note: Other protocol-defined inclusion/exclusion criteria 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-986278Specified dose on specified days | Drug | Treatment B: BMS-986278/DRSP/EE |
| Drospirenone/Ethinyl EstradiolSpecified dose on specified days | Drug | Treatment A: DRSP/EE, Treatment B: BMS-986278/DRSP/EE |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
Time frame: Predose and post-dose up to Day 28
10 secondary outcomes
Time of maximum observed concentration (Tmax)
Time frame: Predose and post-dose up to Day 28
Terminal half-life (T-Half)
Time frame: Predose and post-dose up to Day 28
Apparent total body clearance after extravascular administration (CL/F)
Time frame: Predose and post-dose up to Day 28
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 53
Number of Participants with Serious AEs (SAEs)
Time frame: Up to Day 53
Number of Participants with AEs leading to discontinuation
Time frame: Up to Day 53
Number of Participants with Physical Examination Abnormalities
Time frame: Up to Day 28
Number of Participants with Vital Sign Abnormalities
Time frame: Up to Day 28
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 28
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Up to Day 27
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 24 Jan 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
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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 Drospirenone/Ethinyl Estradiol in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in Canada.
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 4 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 24 Jan 2024. 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 Canada. 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) (time frame: Predose and post-dose up to Day 28). The study lists 3 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 24 Jan 2024.