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NCT04052360 · ClinicalTrials.gov registry record · Phase 1
Single Oral Dose of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects
A Phase 1 study of Healthy Volunteers, sponsored by Viatris Innovation.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04052360: Completed Phase 1 study of Healthy Volunteers, sponsored by Viatris Innovation.
NCT04052360 is a Phase 1 study of Healthy Volunteers that has completed, run by Viatris Innovation. The registered enrollment target is 20 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04052360, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Viatris Innovation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The plasma PK parameter of cenerimod will be derived by non-compartmental analysis of plasma concentration-time profiles.
Conditions Studied
Interventions
- DRUG Cenerimod
- DRUG Matching Placebo
Study Locations (1)
California
- Anaheim Clinical Trials - Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-08-07 |
| Est. Completion | 2019-11-02 |
| Phase | Phase 1 |
What the finished NCT04052360 record still lists
NCT04052360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Cenerimod is the first listed.
NCT04052360 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04052360 about?
NCT04052360 is a clinical study titled "Single Oral Dose of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects". 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. Pharmac...
What is the current status of trial NCT04052360?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-08-07. Estimated completion is 2019-11-02.
What conditions does trial NCT04052360 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04052360?
The interventions under investigation include: Cenerimod (DRUG), Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT04052360?
This trial is sponsored by Viatris Innovation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04052360 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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