A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
32
30 mg(6ml)
1.5 mg Norethindrone and 30ug ethinyl estradiol
Altasciences Los Angeles (Formerly WCCT Global)
Cypress, California, United States
Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)
Time frame: 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
Time frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE)
Time frame: 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)
Time frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Incidence of Adverse Events (AEs)
Time frame: Up to 28 weeks
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 28 weeks
Serology clinical lab assessment of blood
Time frame: up to 28 weeks
Hematology clinical lab assessments of blood
Time frame: up to 28 weeks
Urinalysis clinical lab assessment
Time frame: up to 28 weeks
Vital signs of blood pressure
Time frame: up to 28 weeks
Vital signs of body temperature
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Time frame: up to 28 weeks
Vital signs of respiratory rate
Time frame: up to 28 weeks
Number of Participants with abnormal physical examination findings
Time frame: up to 28 weeks