NCT03657355

Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users

Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, 6-way Cross-over Study to Evaluate the Abuse Potential of Single, Oral Doses of ACT-541468 in Healthy Recreational Drug Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users

Conditions

• Healthy Recreational Drug Users

Interventions

Type	Name	Description
DRUG	ACT-541468	ACT-541468 will be administered as 50 mg tablets for oral use.
DRUG	Suvorexant	Suvorexant will be administered as 15 mg over-encapsulated tablets for oral use.
DRUG	Zolpidem	Zolpidem will be administered as 10 mg over-encapsulated tablets for oral use.
DRUG	Placebo	Matching-placebo will be used.

Timeline

• Start date: 2018-09-07
• Primary completion: 2019-08-08
• Completion: 2019-08-08
• First posted: 2018-09-05
• Last updated: 2019-09-19

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study