A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05985590
• Other study ID #: IM027-1013
• Status: Completed
• Phase: Phase 1
• Start date: August 18, 2023
• Est. completion date: December 11, 2023

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BMS-986278
Specified dose on specified days
• Drospirenone/Ethinyl Estradiol
Specified dose on specified days

Locations

Country	Name	City	State
Canada	Local Institution - 0002	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Predose and post-dose up to Day 28
Primary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])		Predose and post-dose up to Day 28
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])		Predose and post-dose up to Day 28
Secondary	Time of maximum observed concentration (Tmax)		Predose and post-dose up to Day 28
Secondary	Terminal half-life (T-Half)		Predose and post-dose up to Day 28
Secondary	Apparent total body clearance after extravascular administration (CL/F)		Predose and post-dose up to Day 28
Secondary	Number of Participants with Adverse Events (AEs)		Up to Day 53
Secondary	Number of Participants with Serious AEs (SAEs)		Up to Day 53
Secondary	Number of Participants with AEs leading to discontinuation		Up to Day 53
Secondary	Number of Participants with Physical Examination Abnormalities		Up to Day 28
Secondary	Number of Participants with Vital Sign Abnormalities		Up to Day 28
Secondary	Number of Participants with Electrocardiogram (ECG) Abnormalities		Up to Day 28
Secondary	Number of Participants with Clinical Laboratory Abnormalities		Up to Day 27

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting