NCT05549531

A Study to Investigate the Effect of Itraconazole on the Way the Body Absorbs, Distributes, and Gets Rid of ACT-1004-1239 Given as a Single Dose of 10 mg to Healthy Male Subjects

A Single-center, Open-label, Fixed-sequence Study to Investigate the Effect of Multiple-dose Itraconazole on the Pharmacokinetics of a Single Dose of 10 mg ACT-1004-1239 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A study to investigate the effect of itraconazole on the way the body absorbs, distributes, and gets rid of ACT-1004-1239 given as a single dose of 10 mg to healthy male subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ACT-1004-1239 (10 mg)	ACT-1004-1239 will be administered as 1 capsule of 10 mg strength to be taken under fed conditions.
DRUG	Itraconazole (200 mg, o.d.)	Itraconazole 200 mg will be administered as capsules (2 x 100 mg capsule) to be taken under fed conditions.

Timeline

• Start date: 2022-10-01
• Primary completion: 2022-10-20
• Completion: 2022-10-20
• First posted: 2022-09-22
• Last updated: 2022-11-08

Locations

1 site across 1 country: Portugal