CompletedNCT04934696Updated Mar 18, 2022

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

A Phase 1 interventional study of BMS-986166 and Oral contraceptive in Healthy Participants, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-18.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Basic science

From the registry’s dates

Primary completion was Jan 2022, 4 years 8 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 25
Allocation: Not applicable
Ages: 18 Years to 45 Years
Sex: Female

Study summary

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.

Conditions studied

Healthy Participants

Keywords

Healthy Participants
BMS-986166

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

Inclusion criteria

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

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 design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 25 participants (actual)

Study arms

Experimental
BMS-986166 + Oral contraceptive
Drug: BMS-986166 · Drug: Oral contraceptive

Interventions

DrugBMS-986166
Specified dose on specified days
DrugOral contraceptive
Specified dose on specified days

What researchers measure

Primary outcomes

Geometric means ratio of Cmax of NET
Geometric means ratio of maximum observed plasma concentration (Cmax) of norethindrone (NET) when administered with versus without BMS-986166
Time frame: Up to Day 26
Geometric means ratio of Cmax of EE
Geometric means ratio of maximum observed plasma concentration (Cmax) of ethinyl estradiol (EE) when administered with versus without BMS-986166
Time frame: Up to Day 26
Geometric means ratio of AUC(0-T) of NET
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
Time frame: Up to Day 26
Geometric means ratio of AUC(0-T) of EE
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
Time frame: Up to Day 26
Geometric means ratio of AUC(INF) of NET
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
Time frame: Up to Day 26
Geometric means ratio of AUC(INF) of EE
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
Time frame: Up to Day 26

Secondary outcomes

Cmax of BMS-986166
Time frame: Up to Day 26
Cmax of BMT-121795
Time frame: Up to Day 26
Time of maximum observed plasma concentration (Tmax) of BMS-986166
Time frame: Up to Day 26
Tmax of BMT-121795
Time frame: 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
AUC(TAU) of BMT-121795
Time frame: Up to Day 26
Tmax of EE
Time frame: Up to Day 26
Tmax of NET
Time frame: Up to Day 26
Terminal plasma elimination phase half-life (T-HALF) of EE
Time frame: Up to Day 26
T-HALF of NET
Time frame: Up to Day 26
Apparent total clearance of drug from plasma after oral administration (CLT/F) of EE
Time frame: Up to Day 26
CLT/F of NET
Time frame: Up to Day 26
Apparent volume of distribution at terminal phase (Vz/F) of EE
Time frame: Up to Day 26
Vz/F of NET
Time frame: Up to Day 26
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 37
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 37
Number of participants with clinically significant changes in laboratory values: Hematology tests
Time frame: Up to Day 30
Number of participants with clinically significant changes in laboratory values: Chemistry tests
Time frame: Up to Day 30
Number of participants with clinically significant changes in laboratory values: Urinalysis
Time frame: Up to Day 30
Number of participants with clinically significant changes in vital signs: Body temperature
Time frame: Up to Day 27
Number of participants with clinically significant changes in vital signs: Respiratory rate
Time frame: Up to Day 27
Number of participants with clinically significant changes in vital signs: Blood pressure
Time frame: Up to Day 27
Number of participants with clinically significant changes in vital signs: Heart rate
Time frame: Up to Day 27
Number of participants with clinically significant changes in ECG parameters: PR interval
PR interval is the time from the onset of the P wave to the start of the QRS complex
Time frame: Up to Day 27
Number of participants with clinically significant changes in ECG parameters: QRS
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Time frame: Up to Day 27
Number of participants with clinically significant changes in ECG parameters: QT interval
The QT interval is the time from the start of the Q wave to the end of the T wave
Time frame: Up to Day 27
Number of participants with clinically significant changes in ECG parameters: QTcF
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
Time frame: Up to Day 27
Number of participants with physical examination abnormalities
Time frame: Up to Day 27

Study locations

1 site

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

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04934696
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Jun 22, 2021
Start date: Aug 3, 2021
Primary completion: Jan 25, 2022
Completion: Jan 25, 2022
Last update: Mar 18, 2022

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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