NCT03165097

Study to Evaluate Safety and Tolerability of ACT-709478 in Healthy Subjects

A Single-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Multiple-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-709478 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the safety and tolerability of ascending multiple doses of ACT-709478 in healthy male and female subjects

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ACT-709478	Hard gelatine capsules for oral administration
DRUG	Placebo	Placebo capsules matching ACT-709478 capsules
DRUG	Midazolam	Midazolam oral solution (2 mg/mL) applied with a syringe
DRUG	ACT-709478 combined with midazolam	Hard gelatine capsules for oral administration (ACT-709478) to be taken first followed by Midazolam oral solution (2 mg/mL) applied with a syringe

Timeline

• Start date: 2017-07-07
• Primary completion: 2018-11-15
• Completion: 2018-12-28
• First posted: 2017-05-24
• Last updated: 2019-12-24

Locations

1 site across 1 country: Germany