A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential

March 7, 2022 updated by: Bristol-Myers Squibb

A Phase 1 Study to Characterize the Effects of BMS-986166 on the Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone in Healthy Female Participants

The purpose of this study is to investigate the potential for a drug-drug interaction (DDI) when BMS-986166 and hormonal oral contraceptives are co-administered.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • Cypress, California, United States, 90630
        • West Coast Clinical Trials 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

  • Nonpregnant, nonlactating Women of Childbearing Potential (WOCBP) who are healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations will be eligible to participate in the study.
  • Body mass index (BMI) of 18.0 to 32.0 kg/m². BMI = weight (kg)/(height[m])² for participants.
  • Participant must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.

Exclusion Criteria:

  • Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor.
  • History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease.
  • Any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening.

Other protocol-defined inclusion/exclusion criteria apply

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BMS-986166 + Oral contraceptive
Drug: BMS-986166
Specified dose on specified days
Drug: Oral contraceptive
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geometric means ratio of Cmax of NET
Time Frame: Up to Day 26
Geometric means ratio of maximum observed plasma concentration (Cmax) of norethindrone (NET) when administered with versus without BMS-986166
Up to Day 26
Geometric means ratio of Cmax of EE
Time Frame: Up to Day 26
Geometric means ratio of maximum observed plasma concentration (Cmax) of ethinyl estradiol (EE) when administered with versus without BMS-986166
Up to Day 26
Geometric means ratio of AUC(0-T) of NET
Time Frame: Up to Day 26
Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for NET when administered with versus without BMS-986166
Up to Day 26
Geometric means ratio of AUC(0-T) of EE
Time Frame: Up to Day 26
Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for EE when administered with versus without BMS-986166
Up to Day 26
Geometric means ratio of AUC(INF) of NET
Time Frame: Up to Day 26
Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for NET administered with versus without BMS-986166
Up to Day 26
Geometric means ratio of AUC(INF) of EE
Time Frame: Up to Day 26
Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for EE when administered with versus without BMS-986166
Up to Day 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax of BMS-986166
Time Frame: Up to Day 26
Up to Day 26
Cmax of BMT-121795
Time Frame: Up to Day 26
Up to Day 26
Time of maximum observed plasma concentration (Tmax) of BMS-986166
Time Frame: Up to Day 26
Up to Day 26
Tmax of BMT-121795
Time Frame: Up to Day 26
Up to Day 26
Area under the plasma concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986166
Time Frame: Up to Day 26
Up to Day 26
AUC(TAU) of BMT-121795
Time Frame: Up to Day 26
Up to Day 26
Tmax of EE
Time Frame: Up to Day 26
Up to Day 26
Tmax of NET
Time Frame: Up to Day 26
Up to Day 26
Terminal plasma elimination phase half-life (T-HALF) of EE
Time Frame: Up to Day 26
Up to Day 26
T-HALF of NET
Time Frame: Up to Day 26
Up to Day 26
Apparent total clearance of drug from plasma after oral administration (CLT/F) of EE
Time Frame: Up to Day 26
Up to Day 26
CLT/F of NET
Time Frame: Up to Day 26
Up to Day 26
Apparent volume of distribution at terminal phase (Vz/F) of EE
Time Frame: Up to Day 26
Up to Day 26
Vz/F of NET
Time Frame: Up to Day 26
Up to Day 26
Number of participants with Adverse Events (AEs)
Time Frame: Up to Day 37
Up to Day 37
Number of participants with Serious Adverse Events (SAEs)
Time Frame: Up to Day 37
Up to Day 37
Number of participants with clinically significant changes in laboratory values: Hematology tests
Time Frame: Up to Day 30
Up to Day 30
Number of participants with clinically significant changes in laboratory values: Chemistry tests
Time Frame: Up to Day 30
Up to Day 30
Number of participants with clinically significant changes in laboratory values: Urinalysis
Time Frame: Up to Day 30
Up to Day 30
Number of participants with clinically significant changes in vital signs: Body temperature
Time Frame: Up to Day 27
Up to Day 27
Number of participants with clinically significant changes in vital signs: Respiratory rate
Time Frame: Up to Day 27
Up to Day 27
Number of participants with clinically significant changes in vital signs: Blood pressure
Time Frame: Up to Day 27
Up to Day 27
Number of participants with clinically significant changes in vital signs: Heart rate
Time Frame: Up to Day 27
Up to Day 27
Number of participants with clinically significant changes in ECG parameters: PR interval
Time Frame: Up to Day 27
PR interval is the time from the onset of the P wave to the start of the QRS complex
Up to Day 27
Number of participants with clinically significant changes in ECG parameters: QRS
Time Frame: Up to Day 27
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Up to Day 27
Number of participants with clinically significant changes in ECG parameters: QT interval
Time Frame: Up to Day 27
The QT interval is the time from the start of the Q wave to the end of the T wave
Up to Day 27
Number of participants with clinically significant changes in ECG parameters: QTcF
Time Frame: Up to Day 27
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Up to Day 27
Number of participants with physical examination abnormalities
Time Frame: Up to Day 27
Up to Day 27

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM018-006

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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