AZD7325 Single Ascending Dose Study in Healthy Male Japanese Subjects

Healthy Volunteer Clinical Trial

— JSAD  

Official title:

A Phase I,Single-Center,Randomised,Double-Blind,Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7325 in Healthy Male Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769899
• Other study ID #: D1140C00010
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2008
• Last updated: March 17, 2009
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) : 18 to 27 kg/m 2

Exclusion Criteria:

• Clinically relevant disease and/or abnormalities (past or present)

• Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator

• Use of any medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day)

• Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• AZD7325
Capsule for oral, single dose
• Placebo
Placebo capsule for oral, single dose

Locations

Country	Name	City	State
United States	Research Site	Baltimore	Maryland
United States	Research Site	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments.		During the study	Yes
Secondary	Pharmacokinetic parameters for AZD7325		During residential period	No
Secondary	Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects.		During the study	No