Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Combined contraceptives · 1 trial · 1 indication
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...
Combined contraceptives are being studied in healthy subjects as part of a clinical trial evaluating their interaction with the investigational drug cenerimod. The study assesses the effect of cenerimod on the electrical activity of the heart and on the use of oral contraceptives in women, as well as the effect of charcoal on cenerimod elimination.
Combined contraceptives are being developed by Viatris Inc., a company traded on the NASDAQ under the ticker VTRS. The product is in Phase 1 clinical development for use in healthy subjects.
Combined contraceptives are in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the product remains in early-stage clinical testing.
Combined contraceptives are associated with one completed Phase 1 clinical trial, NCT04255277. This study enrolled 97 participants in France and evaluated the effect of cenerimod on heart electrical activity, oral contraceptive use in women, and the impact of charcoal on cenerimod elimination.
No, Combined contraceptives are not the same as cenerimod. Combined contraceptives are the oral contraceptive product being studied in the trial, while cenerimod is the investigational drug being tested. The trial evaluates how cenerimod affects the use of combined oral contraceptives in healthy women.