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

NCT05985590 | Completed Phase 1 FDA Drug

• 1 other identifier: IM027-1013
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; BMS-986278; Hormonal contraceptives; Ethinyl estradiol; Drospirenone; Pulmonary fibrosis

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Predose and post-dose up to Day 28

• 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

• 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 Outcomes (10)

• Time of maximum observed concentration (Tmax)

  Predose and post-dose up to Day 28

• Terminal half-life (T-Half)

  Predose and post-dose up to Day 28

• Apparent total body clearance after extravascular administration (CL/F)

  Predose and post-dose up to Day 28

• Number of Participants with Adverse Events (AEs)

  Up to Day 53

• Number of Participants with Serious AEs (SAEs)

  Up to Day 53

Study Arms (2)

Treatment A: DRSP/EE

EXPERIMENTAL

Drug: Drospirenone/Ethinyl Estradiol

Treatment B: BMS-986278/DRSP/EE

EXPERIMENTAL

Drug: BMS-986278; Drug: Drospirenone/Ethinyl Estradiol

Interventions

BMS-986278 DRUG

Specified dose on specified days

Treatment B: BMS-986278/DRSP/EE

Drospirenone/Ethinyl Estradiol DRUG

Specified dose on specified days

Treatment A: DRSP/EE; Treatment B: BMS-986278/DRSP/EE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0002

Québec, Quebec, G1P 0A2, Canada

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 18, 2023
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)