Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers
NCT ID: NCT00820092
Last Updated: 2013-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2008-12-31
2009-04-30
Brief Summary
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2. To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept administration between healthy Japanese and Caucasian subjects
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Xerecept 1.0
1.0 ug/kg/hr hCRF -24 hour IV infusion
Xerecept 1.0
24 hour infusion
Xerecept 2.0
2.0 ug/kg/hr-24 hour IV infusion
Xerecept 2.0
24 hour infusion
Xerecept 3.0
3.0 ug/kg/hr-24 hour infusion
Xerecept 3.0
24 hour infusion
Interventions
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Xerecept 1.0
24 hour infusion
Xerecept 2.0
24 hour infusion
Xerecept 3.0
24 hour infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy male and female Caucasian subjects
* Age range 20-45 years
* BMI \>19 and \<27 kg/m squared
Exclusion Criteria
* 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
20 Years
45 Years
ALL
Yes
Sponsors
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Celtic Pharma Development Services
INDUSTRY
Responsible Party
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Locations
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West Coast Clinical Trials
Cypress, California, United States
Countries
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Other Identifiers
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Xerecept: CPDS 0805
Identifier Type: -
Identifier Source: org_study_id
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