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

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

none needed

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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