Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celtic Pharma Development Services
ClinicalTrials.gov Identifier:
NCT00820092
First received: December 14, 2008
Last updated: July 29, 2013
Last verified: July 2013
  Purpose
  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

Condition Intervention Phase
Edema
Drug: Xerecept 1.0
Drug: Xerecept 2.0
Drug: Xerecept 3.0
Phase 1

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

Further study details as provided by Celtic Pharma Development Services:

Primary Outcome Measures:
  • 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 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Xerecept 1.0
1.0 ug/kg/hr hCRF -24 hour IV infusion
Drug: Xerecept 1.0
24 hour infusion
Other Names:
  • hCRF infusion
  • 1.0 ug/kg/hr
Active Comparator: Xerecept 2.0
2.0 ug/kg/hr-24 hour IV infusion
Drug: Xerecept 2.0
24 hour infusion
Other Names:
  • hCRF infusion
  • 2.0 ug/kg/hr
Active Comparator: Xerecept 3.0
3.0 ug/kg/hr-24 hour infusion
Drug: Xerecept 3.0
24 hour infusion
Other Names:
  • hCRF infusion
  • 3.0 ug/kg/hr

Detailed Description:

none needed

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820092

Locations
United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Sponsors and Collaborators
Celtic Pharma Development Services
  More Information

No publications provided

Responsible Party: Celtic Pharma Development Services
ClinicalTrials.gov Identifier: NCT00820092     History of Changes
Other Study ID Numbers: Xerecept: CPDS 0805
Study First Received: December 14, 2008
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Celtic Pharma Development Services:
Xerecept
Pharmacokinetics
Japanese versus Caucasians

ClinicalTrials.gov processed this record on October 23, 2014