This is a single-center, randomized, double-blind for cenerimod, open-label for moxifloxacin, placebo- and moxifloxacin-controlled, parallel-group study to investigate the effect of cenerimod on the duration of the QT interval in healthy male and female participants. Participants will be randomly assigned to one of the 4 treatments: placebo, cenerimod 0.5 mg, cenerimod 4 mg or moxifloxacin.
Participants randomized in one of the cenerimod or placebo groups will receive combined oral contraceptives on Day 1 (i.e., prior to cenerimod or placebo administration, Period 1) and on Day 42 (i.e., 36 days after the stat of cenerimod or placebo, Period 2). Half of the participants randomized in one of the cenerimod or placebo groups will be enrolled in an accelerated elimination procedure part (Period 3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
97
A commercially available COC consisting of 0.1mg levonorgestrel and 0.02 mg ethinylestradiol will be used and administered open-label.
A commercially available formulation of moxifloxacin 400 mg will be used and administered open-label. All tablets will be from the same batch.
This will be administered orally as a film-coated tablet in the morning.
This will be administered orally as a film-coated tablet in the morning.
Granules for oral suspension will be used and administered open-label.
Cenerimod matching placebo tablets will be administered once daily orally in the morning.
Site 1
Rennes, France
Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)
ECG variables will be assessed from ECGs extracted in replicates at predefined time points from continuous 24 hour Holter ECG recordings.
Time frame: Day 6, 7, 14, 21, 35, and 56.
Maximum plasma concentration (Cmax): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 1 to Day 3; Day 42 to Day 44
Maximum plasma concentration (Cmax): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 1 to Day 3; Day 42 to Day 44
Time to reach Cmax (tmax): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 1 to Day 3; Day 42 to Day 44
Time to reach Cmax (tmax): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to t (AUC0-t): levonorgestrel
Blood samples for determination of PK parameters will be collected at predefined
Time frame: Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 1 to Day 3; Day 42 to Day 44
The area under the plasma concentration-time curve (AUC) from zero to t (AUC0-t): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 1 to Day 3; Day 42 to Day 44
Terminal elimination half-life (t1/2): levonorgestrel
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 56 to Day 68
Terminal elimination half-life (t1/2): ethinylestradiol
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 56 to Day 68
Terminal elimination half-life (t1/2): cenerimod
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 56 to Day 68
Area under the plasma concentration-time curve (AUC) from Day 56 to infinity (AUC56-inf) for cenerimod
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 56 to Day 68
Change from baseline in total lymphocyte count to each time point
Blood samples (fasting) collected at predefined time points as part of the normal hematology analysis.
Time frame: Day 5, Day 7, Day 14, Day 21, Day 35, Day 56, Day 57, Day 58, Day 1, Day 64, and Day 67
Maximum plasma concentration (Cmax): cenerimod
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 7, Day 14, Day 21, Day 35, and Day 56
Time to reach Cmax (tmax): cenerimod
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 7, Day 14, Day 21, Day 35, and Day 56
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.