West Coast Clinical Trials Global
Cypress, California, 90630, United States
NCT Number: NCT04934696
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.
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Notify Me18 year–45 year
Female
Interventional
Phase 1
Cypress, California, 90630, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria apply
Specified dose on specified days
Specified dose on specified days
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
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
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
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
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
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
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 26
Time frame: Up to Day 37
Time frame: Up to Day 37
Time frame: Up to Day 30
Time frame: Up to Day 30
Time frame: Up to Day 30
Time frame: Up to Day 27
Time frame: Up to Day 27
Time frame: Up to Day 27
Time frame: Up to Day 27
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
Time frame: Up to Day 27
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
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
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
Time frame: Up to Day 27
Bristol-Myers Squibb
Industry
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
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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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