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Healthy ParticipantsPhase 1NCT04934696

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 study testing BMS-986166 and Oral contraceptive in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
BMS-986166 and Oral contraceptive
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
3 Aug 2021to 25 Jan 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • West Coast Clinical Trials Global

    Cypress, California, 90630

Other trials in United States

About this study

Official title: 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.

Being tested
BMS-986166, Oral contraceptive
Keywords
Healthy Participants, BMS-986166

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986166Drug

    Specified dose on specified days

  • Oral contraceptiveDrug

    Specified dose on specified days

Study groups in NCT04934696
Study groupRoleWhat they receive
BMS-986166 + Oral contraceptiveExperimentalNot described
Receives: Drug: BMS-986166; Drug: Oral contraceptive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to Day 26

  2. 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

    Measured: Up to Day 26

  3. 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

    Measured: Up to Day 26

  4. 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

    Measured: Up to Day 26

  5. 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

    Measured: Up to Day 26

  6. 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

    Measured: Up to Day 26

Secondary outcomes (28)

  1. Cmax of BMS-986166

    Measured: Up to Day 26

  2. Cmax of BMT-121795

    Measured: Up to Day 26

  3. Time of maximum observed plasma concentration (Tmax) of BMS-986166

    Measured: Up to Day 26

  4. Tmax of BMT-121795

    Measured: Up to Day 26

  5. Area under the plasma concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986166

    Measured: Up to Day 26

  6. AUC(TAU) of BMT-121795

    Measured: Up to Day 26

  7. Tmax of EE

    Measured: Up to Day 26

  8. Tmax of NET

    Measured: Up to Day 26

  9. Terminal plasma elimination phase half-life (T-HALF) of EE

    Measured: Up to Day 26

  10. T-HALF of NET

    Measured: Up to Day 26

  11. Apparent total clearance of drug from plasma after oral administration (CLT/F) of EE

    Measured: Up to Day 26

  12. CLT/F of NET

    Measured: Up to Day 26

  13. Apparent volume of distribution at terminal phase (Vz/F) of EE

    Measured: Up to Day 26

  14. Vz/F of NET

    Measured: Up to Day 26

  15. Number of participants with Adverse Events (AEs)

    Measured: Up to Day 37

  16. Number of participants with Serious Adverse Events (SAEs)

    Measured: Up to Day 37

  17. Number of participants with clinically significant changes in laboratory values: Hematology tests

    Measured: Up to Day 30

  18. Number of participants with clinically significant changes in laboratory values: Chemistry tests

    Measured: Up to Day 30

  19. Number of participants with clinically significant changes in laboratory values: Urinalysis

    Measured: Up to Day 30

  20. Number of participants with clinically significant changes in vital signs: Body temperature

    Measured: Up to Day 27

  21. Number of participants with clinically significant changes in vital signs: Respiratory rate

    Measured: Up to Day 27

  22. Number of participants with clinically significant changes in vital signs: Blood pressure

    Measured: Up to Day 27

  23. Number of participants with clinically significant changes in vital signs: Heart rate

    Measured: Up to Day 27

  24. 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

    Measured: Up to Day 27

  25. 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

    Measured: Up to Day 27

  26. 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

    Measured: Up to Day 27

  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

    Measured: Up to Day 27

  28. Number of participants with physical examination abnormalities

    Measured: Up to Day 27

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2021
  2. Study start3 Aug 2021
  3. Primary completion25 Jan 2022
  4. Study completion25 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04934696
Sponsor's protocol ID
IM018-006
Status last verified
Mar 2022
First submitted
17 Jun 2021
Last updated
18 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-986166 and Oral contraceptive in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric means ratio of Cmax of NET (time frame: Up to Day 26). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04934696.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.

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