Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

July 29, 2013 updated by: Celtic Pharma Development Services

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

  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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

none needed

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • West Coast Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celtic Pharma Development Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

December 14, 2008

First Submitted That Met QC Criteria

January 7, 2009

First Posted (ESTIMATE)

January 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2013

Last Update Submitted That Met QC Criteria

July 29, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xerecept: CPDS 0805

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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