Status:
COMPLETED
A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
FEMALE
21-40 years
Phase:
PHASE1
Brief Summary
A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04016753
Start Date
August 5 2019
End Date
February 21 2020
Last Update
May 31 2022
Active Locations (1)
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1
Altasciences Los Angeles (Formerly WCCT Global)
Cypress, California, United States, 90630