Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

Phase 1CompletedNCT00820092

Celtic Pharma Development Services38 enrolled

Overview

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

none needed

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Edema

Interventions

Xerecept 1.0DRUG

24 hour infusion

Xerecept 2.0DRUG

24 hour infusion

Xerecept 3.0DRUG

24 hour infusion

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

West Coast Clinical Trials

Cypress, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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