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Completed

NCT Number: NCT04016753

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

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

Completed

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Key information

Conditions

Healthy Participants

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Los Angeles (Formerly WCCT Global)

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986256

Drug

30 mg(6ml)

Loestrin

Drug

1.5 mg Norethindrone and 30ug ethinyl estradiol

Primary outcomes

  1. Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)

    Time frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)

  2. 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)

  3. Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE)

    Time frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)

  4. 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 outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 28 weeks

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 28 weeks

  3. Serology clinical lab assessment of blood

    Time frame: up to 28 weeks

  4. Hematology clinical lab assessments of blood

    Time frame: up to 28 weeks

  5. Urinalysis clinical lab assessment

    Time frame: up to 28 weeks

  6. Vital signs of blood pressure

    Time frame: up to 28 weeks

  7. Vital signs of body temperature

    Time frame: up to 28 weeks

  8. Vital signs of respiratory rate

    Time frame: up to 28 weeks

  9. Number of Participants with abnormal physical examination findings

    Time frame: up to 28 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

The Effect of BMS-986256 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 11, 2019
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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