Clinical trial NCT04016753: A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants
Official title: The Effect of BMS-986256 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-07-11
Enrollment: 32
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Primary outcomes:
measure: Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)
timeFrame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
measure: Area under the plasma concentration-time curve over the dosing interval AUC(TAU) of NET
timeFrame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
measure: Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE)
timeFrame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
measure: Area under the plasma concentration-time curve over the dosing interval AUC(TAU)of (EE)
timeFrame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 28 weeks
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 28 weeks
measure: Serology clinical lab assessment of blood
timeFrame: up to 28 weeks
measure: Hematology clinical lab assessments of blood
timeFrame: up to 28 weeks
measure: Urinalysis clinical lab assessment
timeFrame: up to 28 weeks
measure: Vital signs of blood pressure
timeFrame: up to 28 weeks
measure: Vital signs of body temperature
timeFrame: up to 28 weeks
measure: Vital signs of respiratory rate
timeFrame: up to 28 weeks
measure: Number of Participants with abnormal physical examination findings
timeFrame: up to 28 weeks
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Los Angeles (Formerly WCCT Global)
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: