Overview

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

Status:
Active, not recruiting
Trial end date:
2021-02-01
Target enrollment:
0
Participant gender:
Female
Summary
A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Contraceptive Agents
Contraceptives, Oral
Estradiol
Ethinyl Estradiol
Norethindrone
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Norinyl
Criteria
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.