Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

Completed · Phase 1

Conditions studied: Edema

In brief

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

Key facts

Study ID

NCT00820092

Run by

Celtic Pharma Development Services

People needed

38

Starts

2008-12-01

Expected to finish

2009-04-01

Last updated by the study team

2013-07-30

Who can join

Age: 20 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and female Japanese subjects who are citizens of Japan
• Healthy male and female Caucasian subjects
• Age range 20-45 years
• BMI >19 and <27 kg/m squared

You may not qualify if…

• Female subjects must not be pregnant at the time of study and use adequate birth control methods before,during and 4 weeks after the study
• Subjects must be negative for HCV and HIV
• Subjects must have negative urine tests for drugs of abuse and alcohol at screening
• Subjects must not have any clinically significant medical conditions

Where it is running

• West Coast Clinical Trials — Cypress, California, United States

Full record on ClinicalTrials.gov

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