NCT04123288

A Study to Compare a Single-dose of Two Different Formulations of ACT-709478 in Healthy Men

Single-center, Open-label, Randomized, Two-way Crossover Study to Compare the Single-dose Pharmacokinetics of Pediatric Minitablet and Adult Capsule Formulations of ACT-709478 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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 of 2 different formulations of ACT-709478 in healthy male participants. The participants will be treated in a crossover design with 2 different treatment periods. Pharmacokinetics (PK) is the study of the absorption and breakdown of the study drug in the body. The duration of participation in this study is approximately 8 weeks from screening to the end of study visit. A screening visit is required within 21 to 3 days prior to the start of the study to determine whether the participant qualifies and is willing to enter in this research study. This study requires the participant to have two in-patient stays in the research clinic. Each in-patient stay is planned for 5 days (4 nights). Eleven days after each dose the participant will have an examination. There will be an in-between period (i.e., time between the end of period 1 and study treatment administration in Period 2) of 7 to 14 days. A safety follow-up telephone call for all participants who have received at least one study treatment will take place 30 to 40 days after the end of study examination or study discontinuation.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ACT-709478	1 film-coated minitablet contains 2 mg of ACT-709478
DRUG	ACT-709478	1 hard capsule contains 10 mg of ACT-709478.

Timeline

• Start date: 2019-12-16
• Primary completion: 2020-02-05
• Completion: 2020-02-05
• First posted: 2019-10-10
• Last updated: 2020-02-25

Locations

1 site across 1 country: Czechia