Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820092
• Other study ID #: Xerecept: CPDS 0805
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2008
• Last updated: July 29, 2013
• Start date: December 2008
• Est. completion date: April 2009

Study information

• Verified date: July 2013
• Source: Celtic Pharma Development Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

none needed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema

Intervention

Drug:
• Xerecept 1.0
24 hour infusion
• Xerecept 2.0
24 hour infusion
• Xerecept 3.0
24 hour infusion

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Celtic Pharma Development Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes