Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

Phase 1

Completed

• Conditions: Edema
• Interventions: Drug: Xerecept 1.0; Drug: Xerecept 2.0; Drug: Xerecept 3.0

• Registration Number: NCT00820092
• Lead Sponsor: Celtic Pharma Development Services

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 profile of hCRF during and following a 24-hour intravenous Xerecept administration between healthy Japanese and Caucasian subjects

Detailed Description

none needed

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-14
• Study First Submitted QC: 2009-01-07
• Study First Posted: 2009-01-09
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xerecept 1.0	Xerecept 1.0	1.0 ug/kg/hr hCRF -24 hour IV infusion
Xerecept 2.0	Xerecept 2.0	2.0 ug/kg/hr-24 hour IV infusion
Xerecept 3.0	Xerecept 3.0	3.0 ug/kg/hr-24 hour infusion

Primary Outcome Measures

Name	Time	Method
Frequency and severity of AEs Clinical laboratory tests( chemistry,hematology,urinalysis) Physical exam and vital signs ECG AUC, Tmax Cmax Terminal half life AUC for cortisol concentration	24 hours

Trial Locations

Locations (1)

West Coast Clinical Trials; 🇺🇸 Cypress, California, United States