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Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

Sponsor
Celtic Pharma Development Services (Industry)
Overall Status
Completed
CT.gov ID
NCT00820092
Collaborator
(none)
38
Enrollment
1
Location
3
Arms
4
Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Xerecept 1.0
  • Drug: Xerecept 2.0
  • Drug: Xerecept 3.0
 Phase 1

Detailed Description

none needed

Study Design

Study Type:
Interventional
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 :
Dec 1, 2008
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

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

    		•

    Outcome Measures

    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 [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 West Coast Clinical Trials Cypress California United States 90630

    Sponsors and Collaborators

    • Celtic Pharma Development Services

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celtic Pharma Development Services
    ClinicalTrials.gov Identifier:
    NCT00820092
    Other Study ID Numbers:
    • Xerecept: CPDS 0805
    First Posted:
    Jan 9, 2009
    Last Update Posted:
    Jul 30, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Celtic Pharma Development Services
    Xerecept
    Pharmacokinetics
    Japanese versus Caucasians
    Additional relevant MeSH terms:
    Corticotropin-Releasing Hormone

    Study Results

    No Results Posted as of Jul 30, 2013