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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selatogrel | Experimental | Study treatment is administered in the morning as a subcutaneous single dose. |
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| Placebo | Placebo Comparator | Study treatment is administered in the morning as a subcutaneous single dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selatogrel | Combination Product | Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. A single dose of 16 mg selatogrel will be administered as a liquid formulation from a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) | The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles | Up to 36 hours post-dose |
| Area under the plasma concentration-time curve from zero to infinity (AUC0-infinity) | The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles | Up to 36 hours post-dose |
| Maximum plasma concentration (Cmax) | The measured individual plasma concentrations of selatogrel will be used to directly obtain Cmax | Up to 36 hours post-dose |
| Time to reach maximum plasma concentration (tmax) | The measured individual plasma concentrations of selatogrel will be used to directly obtain tmax | Up to 36 hours post-dose |
| Terminal half-life (t1/2) | The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles | Up to 36 hours post-dose |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel ACT (Anaheim Clinical Trials) | Anaheim | California | 92801 | United States |
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| ID | Term |
|---|---|
| C000601315 | selatogrel |
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| Matching placebo | Combination Product | A single dose of placebo will be administered as a liquid formulation from a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. |
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