NCT01408394

Safety and Tolerability Comparison of Immediate and Controlled Release Formulations of Ecopipam

A Phase 1, Single Center, Randomized (2-Sequence), Single Blind, 3-Period Study Comparing the Safety, Tolerability, and Pharmacokinetics of Ecopipam Controlled Release Capsules With Ecopipam HCl Immediate Release Tablets in Male Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Emalex Biosciences Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible diseases. To date, all clinical studies have been done using the ecopipam immediate release (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been produced that may be able to improve its effectiveness and reduce its side effects. The main purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules when given as single oral dose in healthy volunteers.

Detailed description

Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible diseases. To date, all clinical studies have been done using the ecopipam immediate release (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been produced that may be able to improve its effectiveness and reduce its side effects. The main purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules when given as single oral dose in healthy volunteers. Another purpose of the study is to measure how much CR and IR ecopipam gets into the blood stream, and how long the body takes to get rid of them. Information about any side effects that may occur will be collected.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ecopipam immediate release form	Tablet containing 100 mg of the immediate release form of ecopipam
DRUG	90 mg controlled release form	This is the 90 mg controlled release form
DRUG	180 mg controlled release form	This is the 180 mg controlled release capsule

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-02-01
• Completion: 2012-05-01
• First posted: 2011-08-03
• Last updated: 2024-04-19

Locations

1 site across 1 country: United States