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

Overview

A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together

Full Title of Study: “The Effect of BMS-986256 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2021

Interventions

  • Drug: BMS-986256
    • 30 mg(6ml)
  • Drug: Loestrin
    • 1.5 mg Norethindrone and 30ug ethinyl estradiol

Arms, Groups and Cohorts

  • Experimental: Monotherapy

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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