A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants

NCT05891262 | Completed Phase 1 FDA Drug

• 1 other identifier: IM038-023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of BMS-986196 when coadministered with combined hormonal oral contraceptives (ethinyl estradiol \[EE\] and norethindrone \[NET\]) in healthy female participants.

Conditions

Healthy Female Volunteers

Keywords

Pharmacokinetics; BMS-986196; Hormonal contraceptives; Ethinyl estradiol; Norethindrone; Female volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  At Day 1 and Day 20

• Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])

  At Day 1 and Day 20

• Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])

  At Day 1 and Day 20

Secondary Outcomes (10)

• Time of maximum observed plasma concentration (Tmax)

  At Day 1 and Day 20

• Terminal half-life (T-HALF)

  At Day 1 and Day 20

• Apparent total body clearance (CLT/F)

  At Day 1 and Day 20

• Number of participants with Adverse Events (AEs)

  Up to Day 49

• Number of participants with Serious AEs (SAEs)

  Up to Day 49

Study Arms (1)

BMS-986196 and Loestrin

EXPERIMENTAL

Drug: BMS-986196; Drug: Loestrin

Interventions

BMS-986196 DRUG

Specified dose on specified days

BMS-986196 and Loestrin

Loestrin DRUG

Specified dose on specified days

Also known as: Ethinyl estradiol (EE) and norethindrone (NET)

BMS-986196 and Loestrin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be genetically and hormonally female with intact ovarian function by medical history/menstrual cycles.
• Body mass index between 18.0 and 35.0 kilograms/meter square (kg/m\^2), inclusive, at screening.
• Healthy female participants as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.

You may not qualify if:

• Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor.
• History of clinically significant heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, clinically significant ECG abnormalities, venous thromboembolism, or any congenital heart disease (as assessed by the investigator).
• Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect drug absorption, distribution, metabolism and excretion (for example, bariatric procedure).
• Any major surgery within 4 weeks of study intervention administration, including gastrointestinal surgery that could affect the absorption of study intervention.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Altasciences

Cypress, California, 90630, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Ethinyl Estradiol; Norethindrone

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norpregnenes

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: June 6, 2023
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)