AZD2624 Multiple Ascending Dose Study in Japan

NCT ID: NCT00696865

Last Updated: 2009-07-16

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-08-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

AZD2624

Intervention Type DRUG

oral suspension, 3 doses

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZD2624

oral suspension, 3 doses

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Yuji Kumagai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kitasato University East Hospital, Kanagawa, Japan

Locations

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Research Site

Kanagawa, , Japan

Site Status

Countries

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Japan

Other Identifiers

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D0970C00006

Identifier Type: -

Identifier Source: org_study_id

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