NCT00820092

Brief Summary

  1. 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. 2.To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept administration between healthy Japanese and Caucasian subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2008

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

December 14, 2008

Last Update Submit

July 29, 2013

Conditions

Edema

Keywords

XereceptPharmacokineticsJapanese versus Caucasians

Outcome Measures

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

    24 hours

Study Arms (3)

Xerecept 1.0

ACTIVE COMPARATOR

1.0 ug/kg/hr hCRF -24 hour IV infusion

Drug: Xerecept 1.0

Xerecept 2.0

ACTIVE COMPARATOR

2.0 ug/kg/hr-24 hour IV infusion

Drug: Xerecept 2.0

Xerecept 3.0

ACTIVE COMPARATOR

3.0 ug/kg/hr-24 hour infusion

Drug: Xerecept 3.0

Interventions

Xerecept 1.0DRUG

24 hour infusion

Also known as: hCRF infusion, 1.0 ug/kg/hr
Xerecept 1.0
Xerecept 2.0DRUG

24 hour infusion

Also known as: hCRF infusion, 2.0 ug/kg/hr
Xerecept 2.0
Xerecept 3.0DRUG

24 hour infusion

Also known as: hCRF infusion, 3.0 ug/kg/hr
Xerecept 3.0

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Coast Clinical Trials

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2008

First Posted

January 9, 2009

Study Start

December 1, 2008

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

US(1)