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

An Open-Label, Single-Sequence, Crossover Study to Investigate the Interaction of Multiple Doses of BMS-986322 at Steady State and Multiple Doses of a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986322; Drug: Loestrin

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Local Institution - 0001
    • Anaheim, California, United States, 92801
      • Local Institution - 0002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986322 and Loestrin; Loestrin, then progress to combination	Drug: BMS-986322; Specified dose on specified days; Drug: Loestrin; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of participants with clinical laboratory abnormalities	Up to 119 days
Number of participants with vital sign abnormalities	Up to 119 days
Number of participants with electrocardiogram (ECG) abnormalities	Up to 119 days
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
Number of participants with Serious AEs (SAEs)	Up to 119 days
Number of participants with physical examination abnormalities	Up to 119 days
Time of maximum observed plasma concentration (Tmax) for EE/NET	Up to 28 days
Tmax for EE/NET with BMS-986322	Up to 28 days
Tmax for BMS-986322	Up to 31 days
Tmax for BMS-986322 with EE/NET	Up to 31 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Loestrin; Ethinyl Estradiol; Drug-drug interaction; Norethindrone; BMS-986322; Combined oral hormonal contraceptive
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptives, Oral, Sequential; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
• Other Study ID Numbers: IM032-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No