NCT02526888

Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects

A Single-center, Open-label, Randomized, Two-way Crossover Study to Investigate the Effect of Multiple-dose Diltiazem on the Pharmacokinetics of a Single Dose of 25 mg ACT-541468 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective of this study is to investigate whether repeated administration of a cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of presence in the blood) of ACT-541468

Detailed description

Because ACT-541468 appears to be mainly metabolized by CYP3A4, it is deemed of interest to investigate the potential influence of diltiazem, a well-known CYP3A4 inhibitor on the pharmacokinetic profile of ACT-541468. Safety of the concomitant administration of the two drugs will also be assessed

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ACT-541468	Oral capsule (25 mg) as single dose
DRUG	Diltiazem	Two oral capsules (2 x 120 mg) once daily from Day 1 to Day 7

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-08-18
• Last updated: 2018-07-10

Locations

1 site across 1 country: Germany