AZD2624 Multiple Ascending Dose Study in Japan

Healthy Clinical Trial

— JMAD  

Official title:

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2624 When Given in Multiple Ascending Oral Doses in Young Healthy Male Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696865
• Other study ID #: D0970C00006
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2008
• Last updated: July 15, 2009
• Start date: May 2008
• Est. completion date: August 2008

Study information

• Verified date: July 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy young male Japanese volunteers

Exclusion Criteria:

• Significant illness, as judged by the investigator, within 2 weeks of screening visit or Day 1

• Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit or Day 1

• Blood loss in excess of 200 mL within 30 days of screening visit or Day 1, in excess of 400 mL within 90 days of screening visit or Day 1, or in excess of 1200 mL within 1 year of screening visit or Day 1

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy
• Safety

Intervention

Drug:
• AZD2624
oral suspension, 3 doses
• Placebo

Locations

Country	Name	City	State
Japan	Research Site	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of multiple ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs		All assessments are made at each visit, at least daily, during the study.	Yes
Secondary	To evaluate and characterize the pharmacokinetics of AZD2624 and its metabolites when given orally in multiple ascending doses of AZD2624 to young healthy male Japanese subjects by assessment of drug concentration in plasma		Blood samples will be taken before and after study drug administration.	No
Secondary	Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624		A single blood sample will be obtained	No