A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants

Study Overview
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Brief Summary
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A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together

Official Title
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The Effect of BMS-986256 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986256
* Drug: Loestrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be a non- smoking genetically female, who has normal renal function, willing to use Loestrin, and of childbearing Potential with intact ovarian function. Participants must be healthy, defined as having no clinically significant active or ongoing medical condition Weighing less than or equal to 50 kg and a body mass index between 18.0 and 32.0kg inclusive at screening. Participant must have a negative QuantiFeron- TB Gold test at screening and have a normal pap smear result within 3 years. Exclusion Criteria: Participants who are involuntarily incarcerated, have a significant Chronic medical illness or a history of relevant drug allergy to immunologic or related compounds. Any serious bacterial, fungal, or viral infection within 3 months or a history of recurrent or chronic infection or Risk for TB. A history of any medical condition specifically related to the use of hormonal contraceptives as well as an average intake of more than 21 units of alcohol per week.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monotherapy<br> | Drug: BMS-986256<br>* 30 mg(6ml)<br>Drug: Loestrin<br>* 1.5 mg Norethindrone and 30ug ethinyl estradiol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma Concentration (Cmax) of Norethindrone (NET) |  | Day 21 of cycle 1 and cycle 2 (each cycle is 28 days) | 
| Area under the plasma concentration-time curve over the dosing interval AUC(TAU) of NET |  | Day 21 of cycle 1 and cycle 2 (each cycle is 28 days) | 
| Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE) |  | Day 21 of cycle 1 and cycle 2 (each cycle is 28 days) | 
| Area under the plasma concentration-time curve over the dosing interval AUC(TAU)of (EE) |  | Day 21 of cycle 1 and cycle 2 (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 28 weeks | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 28 weeks | 
| Serology clinical lab assessment of blood |  | up to 28 weeks | 
| Hematology clinical lab assessments of blood |  | up to 28 weeks | 
| Urinalysis clinical lab assessment |  | up to 28 weeks | 
| Vital signs of blood pressure |  | up to 28 weeks | 
| Vital signs of body temperature |  | up to 28 weeks | 
| Vital signs of respiratory rate |  | up to 28 weeks | 
| Number of Participants with abnormal physical examination findings |  | up to 28 weeks |