Healthy Participants
Conditions
Brief summary
A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together
Interventions
DRUGBMS-986256
30 mg(6ml)
DRUGLoestrin
1.5 mg Norethindrone and 30ug ethinyl estradiol
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Urinalysis clinical lab assessment | up to 28 weeks |
| Vital signs of blood pressure | up to 28 weeks |
| Incidence of Adverse Events (AEs) | 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 |
| Vital signs of body temperature | 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 |
Countries
United States
Outcome results
None listed