Healthy ParticipantsPhase 1NCT05579574
A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants
A Phase 1 study testing BMS-986322 and Loestrin in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of multiple doses of BMS-986322 on the pharmacokinetics (PK) of Loestrin components in healthy female participants. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986322 and Loestrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2022to 1 Jun 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the investigator would compromise the conduct, results, or interpretation of the study findings.
- Have a negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 4 weeks prior to the start of study intervention.
- Have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter (mL)/minute (min)/1.732m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Who cannot join
- Any significant acute or chronic medical illness.
- Any acute infection or febrile illness within 7 days before Day 1 of Cycle 2.
- Any history or risk for tuberculosis (TB), specifically participants with 1) current clinical, radiographic or laboratory evidence of active TB; 2) history of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; latent TB that has not been successfully treated.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Local Institution - 0001
Anaheim, California, 92801
Local Institution - 0002
Anaheim, California, 92801
About this study
Official title: An Open-Label, Single-Sequence, Crossover Study to Investigate the Interaction of Multiple Doses of BMS-986322 at Steady State and Multiple Doses of a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants
The purpose of this study is to evaluate the effect of multiple doses of BMS-986322 on the pharmacokinetics (PK) of Loestrin components in healthy female participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986322, Loestrin
- Keywords
- BMS-986322, Loestrin, Combined oral hormonal contraceptive, Ethinyl Estradiol, Norethindrone, Drug-drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986322Drug
Specified dose on specified days
LoestrinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986322 and Loestrin | Experimental | Loestrin, then progress to combination Receives: Drug: BMS-986322; Drug: Loestrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) for EE/NET
Measured: Up to 28 days
Cmax for EE/NET with BMS-986322
Measured: Up to 28 days
Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET
Measured: Up to 28 days
AUC (tau) for EE/NET with BMS-986322
Measured: Up to 28 days
Secondary outcomes (14)
Cmax for BMS-986322
Measured: Up to 31 days
Cmax for BMS-986322 with EE/NET
Measured: Up to 31 days
AUC (tau) for BMS-986322
Measured: Up to 31 days
AUC (tau) for BMS-986322 with EE/NET
Measured: Up to 31 days
Number of participants with Adverse Events (AEs)
Measured: Up to 119 days
Number of participants with Serious AEs (SAEs)
Measured: Up to 119 days
Number of participants with physical examination abnormalities
Measured: Up to 119 days
Number of participants with vital sign abnormalities
Measured: Up to 119 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 119 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 119 days
Time of maximum observed plasma concentration (Tmax) for EE/NET
Measured: Up to 28 days
Tmax for EE/NET with BMS-986322
Measured: Up to 28 days
Tmax for BMS-986322
Measured: Up to 31 days
Tmax for BMS-986322 with EE/NET
Measured: Up to 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start21 Oct 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT05579574
- Sponsor's protocol ID
- IM032-030
- Status last verified
- Aug 2023
- First submitted
- 11 Oct 2022
- Last updated
- 18 Aug 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 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Sequence, Crossover Study to Investigate the Interaction of Multiple Doses of BMS-986322 at Steady State and Multiple Doses of a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants
- ClinicalTrials.gov ID
- NCT05579574
- Acronym / sponsor ID
- IM032-030
- Conditions
- Healthy Participants
- Keywords
- BMS-986322, Loestrin, Combined oral hormonal contraceptive, Ethinyl Estradiol, Norethindrone, Drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 14 Oct 2022 (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 multiple doses of BMS-986322 on the pharmacokinetics (PK) of Loestrin components in healthy female participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986322 and Loestrin | Experimental | Drug: BMS-986322, Drug: LoestrinLoestrin, then progress to combination |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participants, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the investigator would compromise the conduct, results, or interpretation of the study findings.
- Have a negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 4 weeks prior to the start of study intervention.
- Have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter (mL)/minute (min)/1.732m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness.
- Any acute infection or febrile illness within 7 days before Day 1 of Cycle 2.
- Any history or risk for tuberculosis (TB), specifically participants with 1) current clinical, radiographic or laboratory evidence of active TB; 2) history of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; latent TB that has not been successfully treated.
- 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-986322Specified dose on specified days | Drug | BMS-986322 and Loestrin |
| LoestrinSpecified dose on specified days | Drug | BMS-986322 and Loestrin |
Primary outcome
Maximum observed plasma concentration (Cmax) for EE/NET
Time frame: Up to 28 days
Cmax for EE/NET with BMS-986322
Time frame: Up to 28 days
Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET
Time frame: Up to 28 days
AUC (tau) for EE/NET with BMS-986322
Time frame: Up to 28 days
14 secondary outcomes
Cmax for BMS-986322
Time frame: Up to 31 days
Cmax for BMS-986322 with EE/NET
Time frame: Up to 31 days
AUC (tau) for BMS-986322
Time frame: Up to 31 days
AUC (tau) for BMS-986322 with EE/NET
Time frame: Up to 31 days
Number of participants with Adverse Events (AEs)
Time frame: Up to 119 days
Number of participants with Serious AEs (SAEs)
Time frame: Up to 119 days
Number of participants with physical examination abnormalities
Time frame: Up to 119 days
Number of participants with vital sign abnormalities
Time frame: Up to 119 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 119 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 119 days
Time of maximum observed plasma concentration (Tmax) for EE/NET
Time frame: Up to 28 days
Tmax for EE/NET with BMS-986322
Time frame: Up to 28 days
Tmax for BMS-986322
Time frame: Up to 31 days
Tmax for BMS-986322 with EE/NET
Time frame: Up to 31 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 18 Aug 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
2 sites 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-986322 and Loestrin in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites 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 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 18 Aug 2023. 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 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 EE/NET (time frame: Up to 28 days). 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 18 Aug 2023.