Clinical trial NCT05579574: A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: BMS-986322
Loestrin
Combined oral hormonal contraceptive
Ethinyl Estradiol
Norethindrone
Drug-drug interaction
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-10-14
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) for EE/NET
timeFrame: Up to 28 days
measure: Cmax for EE/NET with BMS-986322
timeFrame: Up to 28 days
measure: Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET
timeFrame: Up to 28 days
measure: AUC (tau) for EE/NET with BMS-986322
timeFrame: Up to 28 days
Secondary outcomes:
measure: Cmax for BMS-986322
timeFrame: Up to 31 days
measure: Cmax for BMS-986322 with EE/NET
timeFrame: Up to 31 days
measure: AUC (tau) for BMS-986322
timeFrame: Up to 31 days
measure: AUC (tau) for BMS-986322 with EE/NET
timeFrame: Up to 31 days
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 119 days
measure: Number of participants with Serious AEs (SAEs)
timeFrame: Up to 119 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 119 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 119 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 119 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 119 days
measure: Time of maximum observed plasma concentration (Tmax) for EE/NET
timeFrame: Up to 28 days
measure: Tmax for EE/NET with BMS-986322
timeFrame: Up to 28 days
measure: Tmax for BMS-986322
timeFrame: Up to 31 days
measure: Tmax for BMS-986322 with EE/NET
timeFrame: Up to 31 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Local Institution - 0001
state: California
city: Anaheim
country: United States
facility: Local Institution - 0002
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: