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

May 26, 2022 updated by: Bristol-Myers Squibb

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Cypress, California, United States, 90630
        • Altasciences Los Angeles (Formerly WCCT Global)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy
30 mg(6ml)
1.5 mg Norethindrone and 30ug ethinyl estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)
Time Frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
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)
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)
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)
Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to 28 weeks
Up to 28 weeks
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 28 weeks
Up to 28 weeks
Serology clinical lab assessment of blood
Time Frame: up to 28 weeks
up to 28 weeks
Hematology clinical lab assessments of blood
Time Frame: up to 28 weeks
up to 28 weeks
Urinalysis clinical lab assessment
Time Frame: up to 28 weeks
up to 28 weeks
Vital signs of blood pressure
Time Frame: up to 28 weeks
up to 28 weeks
Vital signs of body temperature
Time Frame: up to 28 weeks
up to 28 weeks
Vital signs of respiratory rate
Time Frame: up to 28 weeks
up to 28 weeks
Number of Participants with abnormal physical examination findings
Time Frame: up to 28 weeks
up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2019

Primary Completion (Actual)

February 21, 2020

Study Completion (Actual)

February 21, 2020

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 11, 2019

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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