NCT02719197

First-in-man Study of Single Ascending Dose of a New Drug for Neurological Disorders

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 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 male adults

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	AC-083	Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg
DRUG	Placebo	Placebo capsules matching AC-083 capsules

Timeline

• Start date: 2016-02-19
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-03-25
• Last updated: 2018-07-10

Locations

1 site across 1 country: Germany