Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

Celtic Pharma Development Services

Status and phase: Completed; Phase 1

Conditions: Edema

Treatments: Drug: Xerecept 3.0; Drug: Xerecept 1.0; Drug: Xerecept 2.0

Study type: Interventional

Funder types: Industry

Identifiers

NCT00820092

Xerecept: CPDS 0805

Details and patient eligibility

About

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

Full description

none needed

Enrollment: 38 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 3 patient groups

Xerecept 1.0

Active Comparator group

Description:

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

Treatment:

Drug: Xerecept 1.0

Xerecept 2.0

Active Comparator group

Description:

2.0 ug/kg/hr-24 hour IV infusion

Treatment:

Drug: Xerecept 2.0

Xerecept 3.0

Active Comparator group

Description:

3.0 ug/kg/hr-24 hour infusion

Treatment:

Drug: Xerecept 3.0