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NCT07133191 · ClinicalTrials.gov registry record · Phase 1
A Trial to Compare What the Body Does to Selatogrel and the Effect of Selatogrel in Japanese and Caucasian Healthy Participants
A Phase 1 study, sponsored by Viatris Innovation.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT07133191 is a Phase 1 study that has completed, run by Viatris Innovation. The registered enrollment target is 32 participants.
The verdict
NCT07133191, a Phase 1 study, has completed, sponsored by Viatris Innovation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
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 pharmacokinetics (PK), pharmacodynamics (PD), and tolerability of selatogrel 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: 16 Japanese participants in one group and 16 Caucasian participants in the other group. The duration of participation in this study is approximately 70 days from screening to the end of follow-up. A screening visit is required within 28 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 3 or 4 days (2 or 3 nights), an end-of-trial (EOT) examination at least 36 hours after study drug administration, and a post-trial safety follow-up telephone call or site visit 30-40 days after the EOT examination.
Interventions
- COMBINATION_PRODUCT Selatogrel
- COMBINATION_PRODUCT Matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2025-10-07 |
| Est. Completion | 2025-11-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07133191
The ClinicalTrials.gov registry entry for NCT07133191 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Viatris Innovation, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Selatogrel is the first listed.
NCT07133191 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07133191 about?
NCT07133191 is a clinical study titled "A Trial to Compare What the Body Does to Selatogrel and the Effect of Selatogrel in Japanese and Caucasian Healthy Participants". 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 pharmacokinetics (PK), pharmacodynamics (PD), and tolerability of selatogrel following a single dose in healthy Japanese and Caucasian participants. Pharmacokinet...
What is the current status of trial NCT07133191?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2025-10-07. Estimated completion is 2025-11-06.
What interventions are being tested in trial NCT07133191?
The interventions under investigation include: Selatogrel (COMBINATION_PRODUCT), Matching placebo (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07133191?
This trial is sponsored by Viatris Innovation, which has 11 total clinical trials registered on ClinicalTrials.gov.
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