We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00820092
First Posted: January 9, 2009
Last Update Posted: July 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celtic Pharma Development Services
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820092


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

Responsible Party: Celtic Pharma Development Services
ClinicalTrials.gov Identifier: NCT00820092     History of Changes
Other Study ID Numbers: Xerecept: CPDS 0805
First Submitted: December 14, 2008
First Posted: January 9, 2009
Last Update Posted: July 30, 2013
Last Verified: July 2013

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