Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of cenerimod following a single dose in healthy Japanese and Caucasian participants. Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Pharmacodynamics is the study of the effect of the study drug on the body. There will be 2 groups in the study. 10 Japanese participants in one group and 10 Caucasian participants in the other group.
The duration of participation in this study is approximately 75 days from screening to the end of study visit. A screening visit is required within 21 days prior to the start of the study to determine whether the volunteer qualifies and is willing to participate in this research study. This study requires in-patient stay in the research clinic of 4 days (3 nights) followed by outpatient visits and an end of study visit 3 to 5 days after the day 49 outpatient visit.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cenerimod / ACT-334441 | Experimental |
| |
| Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenerimod | Drug | A single oral dose of 4 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma concentration-time curve (AUC) for cenerimod | The plasma PK parameter of cenerimod will be derived by non-compartmental analysis of plasma concentration-time profiles. | From Day 1 to Day 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) for cenerimod | The plasma PK parameter of cenerimod will be derived by non-compartmental analysis of plasma concentration-time profiles. | From Day 1 to Day 49 |
| Time to reach the maximum plasma concentration (tmax) for cenerimod |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000709569 | cenerimod |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Matching Placebo | Drug | A single oral dose of matching placebo will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions. |
|
The plasma PK parameter of cenerimod will be derived by non-compartmental analysis of plasma concentration-time profiles. |
| From Day 1 to Day 49 |
| Terminal half-life [t(1/2)] of cenerimod | The plasma PK parameter of cenerimod will be derived by non-compartmental analysis of plasma concentration-time profiles. | From Day 1 to Day 49 |
| Lymphocyte count | The lymphocyte count will be used as a measure of immunomodulation (a change in the body's immune system). | Day 1, Day 3, Day 6, Day 9, Day 12, Day 15, Day 18, Day 21, Day 28, Day 35, Day 42 and Day 49 |