NCT00820092

Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

A Phase 1,Dose Escalation Study to Compare the Safety, Tolerability,Pharmacokinetic and Pharmacodynamic Profiles of the 24-hour Intravenous Administration of Xerecept in Healthy Japanese and Caucasian Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Celtic Pharma Development Services · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

1. To investigate the safety and tolerability of Xerecept during and following a 24-hour intravenous administration to healthy Japanese to healthy Japanese and Caucasian subjects 2. To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept administration between healthy Japanese and Caucasian subjects

Detailed description

none needed

Conditions

• Edema

Interventions

Type	Name	Description
DRUG	Xerecept 1.0	24 hour infusion
DRUG	Xerecept 2.0	24 hour infusion
DRUG	Xerecept 3.0	24 hour infusion

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2009-01-09
• Last updated: 2013-07-30

Locations

1 site across 1 country: United States