Healthy Female VolunteersPhase 1NCT05891262
A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants
A Phase 1 study testing BMS-986196 and Loestrin in people with Healthy Female Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of BMS-986196 when coadministered with combined hormonal oral contraceptives (ethinyl estradiol [EE] and norethindrone [NET]) in healthy female participants. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Female Volunteers
- What is being tested?
- BMS-986196 and Loestrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to 25 Aug 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be genetically and hormonally female with intact ovarian function by medical history/menstrual cycles.
- Body mass index between 18.0 and 35.0 kilograms/meter square (kg/m^2), inclusive, at screening.
- Healthy female participants as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.
Who cannot join
- Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor.
- History of clinically significant heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, clinically significant ECG abnormalities, venous thromboembolism, or any congenital heart disease (as assessed by the investigator).
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect drug absorption, distribution, metabolism and excretion (for example, bariatric procedure).
- Any major surgery within 4 weeks of study intervention administration, including gastrointestinal surgery that could affect the absorption of study intervention.
- 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, Single-center, Open-label, Single-sequence Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 With Oral Contraceptives in Healthy Female Participants
The purpose of this study is to evaluate the effect of BMS-986196 when coadministered with combined hormonal oral contraceptives (ethinyl estradiol [EE] and norethindrone [NET]) in healthy female participants.
- Conditions
- Healthy Female Volunteers
- Being tested
- BMS-986196, Loestrin
- Keywords
- Pharmacokinetics, BMS-986196, Hormonal contraceptives, Ethinyl estradiol, Norethindrone, Female volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986196Drug
Specified dose on specified days
LoestrinDrug
Also called Ethinyl estradiol (EE) and norethindrone (NET)
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986196 and Loestrin | Experimental | Not described Receives: Drug: BMS-986196; Drug: Loestrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: At Day 1 and Day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Measured: At Day 1 and Day 20
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
Measured: At Day 1 and Day 20
Secondary outcomes (10)
Time of maximum observed plasma concentration (Tmax)
Measured: At Day 1 and Day 20
Terminal half-life (T-HALF)
Measured: At Day 1 and Day 20
Apparent total body clearance (CLT/F)
Measured: At Day 1 and Day 20
Number of participants with Adverse Events (AEs)
Measured: Up to Day 49
Number of participants with Serious AEs (SAEs)
Measured: Up to Day 49
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 49
Number of participants with vital sign abnormalities
Measured: Up to Day 49
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 49
Number of participants with physical examination abnormalities
Measured: Up to Day 49
Number of participants with any abnormal columbia-suicide severity rating scale (C-SSRS)
Measured: Up to Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start6 Jun 2023
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Female 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT05891262
- Sponsor's protocol ID
- IM038-023
- Status last verified
- Sep 2023
- First submitted
- 26 May 2023
- Last updated
- 25 Sep 2023
- 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/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label, Single-sequence Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 With Oral Contraceptives in Healthy Female Participants
- ClinicalTrials.gov ID
- NCT05891262
- Acronym / sponsor ID
- IM038-023
- Conditions
- Healthy Female Volunteers
- Keywords
- Pharmacokinetics, BMS-986196, Hormonal contraceptives, Ethinyl estradiol, Norethindrone, Female volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 6 Jun 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 this study is to evaluate the effect of BMS-986196 when coadministered with combined hormonal oral contraceptives (ethinyl estradiol [EE] and norethindrone [NET]) in healthy female 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-986196 and Loestrin | Experimental | Drug: BMS-986196, Drug: Loestrin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must be genetically and hormonally female with intact ovarian function by medical history/menstrual cycles.
- Body mass index between 18.0 and 35.0 kilograms/meter square (kg/m^2), inclusive, at screening.
- Healthy female participants as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.
Key exclusion criteria (5 listed)
- Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor.
- History of clinically significant heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, clinically significant ECG abnormalities, venous thromboembolism, or any congenital heart disease (as assessed by the investigator).
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect drug absorption, distribution, metabolism and excretion (for example, bariatric procedure).
- Any major surgery within 4 weeks of study intervention administration, including gastrointestinal surgery that could affect the absorption of study intervention.
- 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-986196Specified dose on specified days | Drug | BMS-986196 and Loestrin |
| LoestrinAlso: Ethinyl estradiol (EE) and norethindrone (NET)Specified dose on specified days | Drug | BMS-986196 and Loestrin |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: At Day 1 and Day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: At Day 1 and Day 20
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
Time frame: At Day 1 and Day 20
10 secondary outcomes
Time of maximum observed plasma concentration (Tmax)
Time frame: At Day 1 and Day 20
Terminal half-life (T-HALF)
Time frame: At Day 1 and Day 20
Apparent total body clearance (CLT/F)
Time frame: At Day 1 and Day 20
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 49
Number of participants with Serious AEs (SAEs)
Time frame: Up to Day 49
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 49
Number of participants with vital sign abnormalities
Time frame: Up to Day 49
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 49
Number of participants with physical examination abnormalities
Time frame: Up to Day 49
Number of participants with any abnormal columbia-suicide severity rating scale (C-SSRS)
Time frame: Up to Day 49
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 25 Sep 2023.
- 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/disclosurecommitment.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-986196 and Loestrin in people with Healthy Female Volunteers, 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 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: finished, as of the sponsor's last update on 25 Sep 2023. 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) (time frame: At Day 1 and Day 20). 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 25 Sep 2023.