Status:
COMPLETED
Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers
Lead Sponsor:
Celtic Pharma Development Services
Conditions:
Edema
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
none needed
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00820092
Start Date
December 1 2008
End Date
April 1 2009
Last Update
July 30 2013
Active Locations (1)
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1
West Coast Clinical Trials
Cypress, California, United States, 90630