NCT03609775

A Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects

A Double-blind, Randomized, Placebo-controlled, Double-dummy, Four-way Crossover Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A study to investigate the drug-drug interactions between ACT-541468 and ethanol in healthy subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ACT-541468	One tablet of 50 mg ACT-541468 will be administered orally.
OTHER	ACT-541468 placebo	Matching ACT-541468 placebo will be administered orally as 1 tablet.
OTHER	Ethanol 10%	Ethanol 10% w/v solution in 5% glucose will be administered i.v. for 5 h and clamped at an ethanol level of 0.6 g/L.
OTHER	Ethanol placebo	Matching placebo for the ethanol infusion (i.e., 5% glucose solution) will be administered i.v. for 5 h.

Timeline

• Start date: 2018-08-28
• Primary completion: 2018-10-09
• Completion: 2018-10-09
• First posted: 2018-08-01
• Last updated: 2018-10-15

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study