A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants
- Registration Number
- NCT04016753
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Monotherapy Loestrin - Monotherapy BMS-986256 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Incidence of Serious Adverse Events (SAEs) Up to 28 weeks Incidence of Adverse Events (AEs) Up to 28 weeks Vital signs of body temperature 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 respiratory rate up to 28 weeks Number of Participants with abnormal physical examination findings up to 28 weeks
Trial Locations
- Locations (1)
Altasciences Los Angeles (Formerly WCCT Global)
🇺🇸Cypress, California, United States