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Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00820092
Enrollment
38
Registered
2009-01-09
Start date
2008-12-31
Completion date
2009-04-30
Last updated
2013-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edema

Keywords

Xerecept, Pharmacokinetics, Japanese versus Caucasians

Brief summary

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

Detailed description

none needed

Interventions

DRUGXerecept 1.0

24 hour infusion

DRUGXerecept 2.0

24 hour infusion

DRUGXerecept 3.0

24 hour infusion

Sponsors

Celtic Pharma Development Services
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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 concentration24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026