NCT03430661

A Study to Investigate the Interaction Between ACT-246475 and Clopidogrel, Prasugrel, and Ticagrelor in Healthy Subjects

Single-center, Double-blind (ACT-246475), Open-label (Clopidogrel, Prasugrel, and Ticagrelor), Placebo-controlled, Randomized, Two-way Crossover Study to Investigate the Pharmacodynamics, Safety, and Tolerability of a Single Oral Dose of Clopidogrel or, Prasugrel, or Ticagrelor When Administered After a Single Subcutaneous Dose of the P2Y12 Antagonist ACT-246475 in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the pharmacodynamic (PD) effects of clopidogrel, prasugrel, and ticagrelor when administered after a single subcutaneous (s.c.) dose of ACT-246475 in healthy male and female subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ACT-246475	Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection
DRUG	Clopidogrel	Tablet for oral administration (300 or 600 mg)
DRUG	Prasugrel	Tablet for oral administration (60 mg)
DRUG	Placebo	Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution
DRUG	Ticagrelor	Tablet for oral administration (180 mg)

Timeline

• Start date: 2018-01-24
• Primary completion: 2019-05-20
• Completion: 2019-05-29
• First posted: 2018-02-13
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study