Single-Dose Safety Study of APD791 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00529646
• Lead Sponsor: Arena Pharmaceuticals

Brief Summary

The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791 when administered as a single oral dose to healthy adult subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-09-12
• Study First Submitted QC: 2007-09-13
• Study First Posted: 2007-09-14
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-29
• Last Update Posted: 2008-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Healthy adult men and women, ages 19-45
• Non smokers

Exclusion Criteria

• History of a bleeding disorder
• Recently donated blood or had significant blood loss
• Current use of a prescription medication
• Pregnant females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic and pharmacodynamic assessments

Trial Locations

Locations (1)

MDS Pharma Services; 🇺🇸 Lincoln, Nebraska, United States