Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04255277 | To Study the Effect of Cenerimod on the Electrical Activity of the Heart, in Men and Women. To Study the Effect of Cenerimod on the Use of Oral Contraceptives in Women. To Study the Effect That Charcoal Has on the Elimination of Cenerimod From the Body, in Women and Men. | PHASE1 | COMPLETED | 97 | — | — | Jan 31, 2020 | Oct 18, 2021 | Sep 22, 2025 | 1 | France |
ECG variables will be assessed from ECGs extracted in replicates at predefined time points from continuous 24 hour Holter ECG recordings.
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Blood samples for determination of PK parameters will be collected at predefined
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
Blood samples for determination of pharmacokinetic parameters will be collected at multiple predefined time points.
| Arm | Type | Description |
|---|---|---|
| Period 1: First administration of combined oral contraceptives | OTHER | Participants randomized to placebo or cenerimod will receive a single oral dose of levonorgestrel (100 μg) and ethinylestradiol (20 μg) in the morning on Day 1. |
| Period 2: Second administration of Combined Oral Contraceptive | OTHER | Participants randomized to placebo or cenerimod will receive a single oral dose of levonorgestrel (100 μg) and ethinylestradiol (20 μg) in the morning on Day 42. |
| Period 2: Cenerimod 0.5 mg | EXPERIMENTAL | Participants randomized to cenerimod 0.5 mg will receive a single oral dose in the morning from Day 7 to Day 56. |
| Period 2: Cenerimod 4 mg | EXPERIMENTAL | Participants randomized to cenerimod 4 mg will receive a single oral dose in the morning from Day 7 to Day 56. |
| Period 2: Moxifloxacin | OTHER | Participants randomized to moxifloxacin will receive a single oral 400 mg dose in the morning of Day 42. |
| Period 2: Placebo | PLACEBO_COMPARATOR | Participants randomized to placebo will receive a single oral dose of placebo in the morning from Day 7 to Day 56. |
| Period 3: Cenerimod 0.5 mg and charcoal | EXPERIMENTAL | Participants randomized to cenerimod 0.5 mg in Period 2 will receive 50 g of activated charcoal every 12 hours from Day 57 to Day 67. |
| Period 3: Cenerimod 4 mg and charcoal | EXPERIMENTAL | Participants randomized to cenerimod 4 mg in Period 2 will receive 50 g of activated charcoal every 12 hours from Day 57 to Day 67. |
| Period 3: Cenerimod elimination period | NO_INTERVENTION | Participants randomized to cenerimod 0.5 mg or 4 mg in Period 2 will receive no treatment (i.e., activated charcoal from Day 57 to Day 67) but will have blood samples taken. |
| Name | Type | Description |
|---|---|---|
| Combined oral contraceptives (COC) | DRUG | A commercially available COC consisting of 0.1mg levonorgestrel and 0.02 mg ethinylestradiol will be used and administered open-label. |
| Moxifloxacin 400mg | DRUG | A commercially available formulation of moxifloxacin 400 mg will be used and administered open-label. All tablets will be from the same batch. |
| Cenerimod 0.5 mg | DRUG | This will be administered orally as a film-coated tablet in the morning. |
| Cenerimod 4 mg | DRUG | This will be administered orally as a film-coated tablet in the morning. |
| Charcoal, activated | OTHER | Granules for oral suspension will be used and administered open-label. |
| Matching Placebo | DRUG | Cenerimod matching placebo tablets will be administered once daily orally in the morning. |
Inclusion Criteria: * Signed informed consent in a language understandable to the participant prior to any study-mandated procedure. * Body mass index of 18.0 to 29.9 kg/m\^2 (inclusive) at the screening. * No clinically relevant findings on the physical examination at screening. * Systolic blood p...