AZD7325 Japan Multiple Ascending Dose (MAD) Study

NCT ID: NCT00945425

Last Updated: 2011-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and tolerability after repeated ascending doses of AZD7325 in Japanese healthy male subjects.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Low dose or placebo, twice daily

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

oral capsule, once or twice daily, 7 days

Placebo

Intervention Type DRUG

oral capsule, once or twice daily, 7 days

2

Low dose or placebo, once daily

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

oral capsule, once or twice daily, 7 days

Placebo

Intervention Type DRUG

oral capsule, once or twice daily, 7 days

3

Middle dose or placebo, twice daily

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

oral capsule, once or twice daily, 7 days

Placebo

Intervention Type DRUG

oral capsule, once or twice daily, 7 days

4

High dose or placebo, once daily

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

oral capsule, once or twice daily, 7 days

Placebo

Intervention Type DRUG

oral capsule, once or twice daily, 7 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD7325

oral capsule, once or twice daily, 7 days

Intervention Type DRUG

Placebo

oral capsule, once or twice daily, 7 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Japanese subjects

Exclusion Criteria

* Significant illness, as judged by the investigator, within 2 weeks of Day 1
* Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit
* Blood loss in excess of 200 mL within 30 days of Day 1, in excess of 400 mL within 90 days of Day 1, or in excess of 1200 mL within 1 year of Day 1
* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca Pharmaceuticals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yuji Kumagai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kitasato University East Hospital, Kanagawa, Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D1140C00015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AZD7325 Multiple Ascending Dose Study
NCT00681915 COMPLETED PHASE1
AZD5985 Single Ascending Dose Study
NCT00967356 TERMINATED PHASE1