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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05579574
• Other study ID #: IM032-030
• Status: Completed
• Phase: Phase 1
• Start date: October 21, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: August 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986322
Specified dose on specified days
• Loestrin
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Anaheim	California
United States	Local Institution - 0002	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) for EE/NET		Up to 28 days
Primary	Cmax for EE/NET with BMS-986322		Up to 28 days
Primary	Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET		Up to 28 days
Primary	AUC (tau) for EE/NET with BMS-986322		Up to 28 days
Secondary	Cmax for BMS-986322		Up to 31 days
Secondary	Cmax for BMS-986322 with EE/NET		Up to 31 days
Secondary	AUC (tau) for BMS-986322		Up to 31 days
Secondary	AUC (tau) for BMS-986322 with EE/NET		Up to 31 days
Secondary	Number of participants with Adverse Events (AEs)		Up to 119 days
Secondary	Number of participants with Serious AEs (SAEs)		Up to 119 days
Secondary	Number of participants with physical examination abnormalities		Up to 119 days
Secondary	Number of participants with vital sign abnormalities		Up to 119 days
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 119 days
Secondary	Number of participants with clinical laboratory abnormalities		Up to 119 days
Secondary	Time of maximum observed plasma concentration (Tmax) for EE/NET		Up to 28 days
Secondary	Tmax for EE/NET with BMS-986322		Up to 28 days
Secondary	Tmax for BMS-986322		Up to 31 days
Secondary	Tmax for BMS-986322 with EE/NET		Up to 31 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting