NCT02331433

Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects

A Phase 1 Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APN1125 in Healthy Normal Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: CoMentis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.

Detailed description

The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect of food upon pharmacokinetics of a single dose of APN1125 in healthy adult volunteers.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	APN1125	APN1125 orally at ascending doses
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-01-06
• Last updated: 2016-04-08

Locations

1 site across 1 country: United States