Site 1
Rennes, 35042, France
NCT Number: NCT04255277
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Rennes, 35042, France
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A commercially available COC consisting of 0.1mg levonorgestrel and 0.02 mg ethinylestradiol will be used and administered open-label.
Other names: Levonorgestrel/Ethinylestradiol
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.
Other names: ACT-334441
This will be administered orally as a film-coated tablet in the morning.
Other names: ACT-334441
Granules for oral suspension will be used and administered open-label.
Other names: Carbomix 50g
Cenerimod matching placebo tablets will be administered once daily orally in the morning.
Time frame: Day 6, 7, 14, 21, 35, and 56.
ECG variables will be assessed from ECGs extracted in replicates at predefined time points from continuous 24 hour Holter ECG recordings.
Time frame: Day 1 to Day 3; Day 42 to Day 44
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
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
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
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
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
Blood samples for determination of PK parameters will be collected at predefined
Time frame: Day 1 to Day 3; Day 42 to Day 44
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
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 56 to Day 68
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 56 to Day 68
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 56 to Day 68
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Time frame: Day 56 to Day 68
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
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
Blood samples (fasting) collected at predefined time points as part of the normal hematology analysis.
Time frame: Day 7, Day 14, Day 21, Day 35, and Day 56
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
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Viatris Innovation GmbH
Industry
A Single-center, Double-blind for Cenerimod, Open-label for Moxifloxacin, Placebo-controlled, Parallel-group, Randomized Study in Healthy Male and Female Subjects to Investigate I: the Effect of Cenerimod on the QTc Interval II: the Effect of Cenerimod on the Pharmacokinetics of Combined Oral Contraceptives III: the Effect of Charcoal on the Pharmacokinetics of Cenerimod.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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