NCT02479204

Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441

Single-center, Open-label, Randomized, Multiple-dose, Parallel-group Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441 Combined With Calcium-channel Blocker (Diltiazem) or Beta-blocker (Atenolol) Treatment in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to investigate the safety of the concomitant administration of ACT-334441 with cardiovascular drugs.

Detailed description

The study will consist of two parts: a pilot part (Part A) that will be completed prior to the start of the main part (Part B). The Subjects who will participate in Part A are excluded from Part B.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ACT-334441 2 mg	capsule containing ACT-334441 at a strength of 2 mg
DRUG	ACT-334441 4 mg	capsule containing ACT-334441 at a strength of 4 mg
DRUG	Placebo	ACT-33441-matching placebo
DRUG	Atenolol	film-coated tablet containing atenolol at a strength of 50 mg
DRUG	Diltiazem ER	film-coated tablet containing diltiazem at a strength of of 120 mg

Timeline

• Start date: 2015-04-28
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-06-24
• Last updated: 2025-09-22

Locations

1 site across 1 country: France