A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants

NCT05579574 | Completed Phase 1 FDA Drug

• 1 other identifier: IM032-030
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Participants

Keywords

BMS-986322; Loestrin; Combined oral hormonal contraceptive; Ethinyl Estradiol; Norethindrone; Drug-drug interaction

Outcome Measures

Primary Outcomes (4)

• Maximum observed plasma concentration (Cmax) for EE/NET

  Up to 28 days

• Cmax for EE/NET with BMS-986322

  Up to 28 days

• Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET

  Up to 28 days

• AUC (tau) for EE/NET with BMS-986322

  Up to 28 days

Secondary Outcomes (14)

• Cmax for BMS-986322

  Up to 31 days

• Cmax for BMS-986322 with EE/NET

  Up to 31 days

• AUC (tau) for BMS-986322

  Up to 31 days

• AUC (tau) for BMS-986322 with EE/NET

  Up to 31 days

• Number of participants with Adverse Events (AEs)

  Up to 119 days

Study Arms (1)

BMS-986322 and Loestrin

EXPERIMENTAL

Loestrin, then progress to combination

Drug: BMS-986322; Drug: Loestrin

Interventions

BMS-986322 DRUG

Specified dose on specified days

BMS-986322 and Loestrin

Loestrin DRUG

Specified dose on specified days

BMS-986322 and Loestrin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Anaheim, California, 92801, United States

Location

Local Institution - 0002

Anaheim, California, 92801, 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

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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: October 21, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)