Clinical trial NCT05985590: A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
BMS-986278
Hormonal contraceptives
Ethinyl estradiol
Drospirenone
Pulmonary fibrosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Predose and post-dose up to Day 28
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
timeFrame: Predose and post-dose up to Day 28
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
timeFrame: Predose and post-dose up to Day 28
Secondary outcomes:
measure: Time of maximum observed concentration (Tmax)
timeFrame: Predose and post-dose up to Day 28
measure: Terminal half-life (T-Half)
timeFrame: Predose and post-dose up to Day 28
measure: Apparent total body clearance after extravascular administration (CL/F)
timeFrame: Predose and post-dose up to Day 28
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 53
measure: Number of Participants with Serious AEs (SAEs)
timeFrame: Up to Day 53
measure: Number of Participants with AEs leading to discontinuation
timeFrame: Up to Day 53
measure: Number of Participants with Physical Examination Abnormalities
timeFrame: Up to Day 28
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to Day 28
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 28
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to Day 27
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Local Institution - 0002
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: