Trials / Completed
CompletedNCT04557280
A Comparative Study of Selatogrel (ACT-246475) Formulations in Healthy Subjects
A Randomized, Open-label, 3-period Cross-over Study to Assess the Pharmacokinetics of Selatogrel (ACT-246475) in Healthy Subjects After Subcutaneous Administration by Syringe and Auto-injector
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Viatris Innovation GmbH · Industry
- Sex
- All
- Age
- 18 Years – 59 Years
- Healthy volunteers
- Accepted
Summary
The main purpose is to study the pharmacokinetics of selatogrel (ACT-246475) using different administration modes and formulations. The clinical pharmacology data will be used to support demonstration of bioequivalence and interchangeability of the different formulations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Selatogrel | A single subcutaneous injection of 16 mg. |
| DRUG | Selatogrel | A single subcutaneous injection of 16 mg. |
Timeline
- Start date
- 2020-11-06
- Primary completion
- 2020-12-19
- Completion
- 2020-12-19
- First posted
- 2020-09-21
- Last updated
- 2025-07-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04557280. Inclusion in this directory is not an endorsement.