NCT02702648

First-in-man Study of Single and Multiple Ascending Doses of a New Drug for Neurological Disorders

Single-center, Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	AC-082	Hard gelatin capsules for oral administration
DRUG	Placebo	Matched placebo capsules for oral administration

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-03-06
• Completion: 2017-03-06
• First posted: 2016-03-09
• Last updated: 2018-07-10

Locations

1 site across 1 country: Germany