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Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

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. Identifier: NCT00820092
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Edema Drug: Xerecept 1.0 Drug: Xerecept 2.0 Drug: Xerecept 3.0 Phase 1

Detailed Description:
none needed

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
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
Study Start Date : December 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00820092

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United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Sponsors and Collaborators
Celtic Pharma Development Services
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Responsible Party: Celtic Pharma Development Services Identifier: NCT00820092    
Other Study ID Numbers: Xerecept: CPDS 0805
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013
Keywords provided by Celtic Pharma Development Services:
Japanese versus Caucasians
Additional relevant MeSH terms:
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Corticotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs