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OpenTrials
Completed

NCT Number: NCT00820092

Xerecept Intravenous Dose Escalation in Japanese and Caucasian 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

Completed

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Key information

Conditions

Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West Coast Clinical Trials

Cypress, California, 90630, United States

About this study

none needed

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xerecept 1.0

Drug

24 hour infusion

Other names: hCRF infusion, 1.0 ug/kg/hr

Xerecept 2.0

Drug

24 hour infusion

Other names: hCRF infusion, 2.0 ug/kg/hr

Xerecept 3.0

Drug

24 hour infusion

Other names: hCRF infusion, 3.0 ug/kg/hr

Primary outcomes

  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

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Completed

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Sponsors and collaborators

Lead sponsor

Celtic Pharma Development Services

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 9, 2009
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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