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

Resource links provided by NLM:


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
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

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014