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A Study to Evaluate Safety and Tolerability After Single Oral Dosing of AZD1656 in Japanese Healthy Volunteers

NCT ID: NCT00741689

Last Updated: 2010-12-03

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in Japanese healthy male subjects

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Japanese healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

AZD1656 in 6 increasing oral single doses given to 6 groups (5 on active and 1 on placebo in each group)

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Dose escalation of oral single doses of AZD1656 to achieve maximal tolerated dose

Interventions

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AZD1656

Dose escalation of oral single doses of AZD1656 to achieve maximal tolerated dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese males aged ≥20 and ≤40 years of age
* Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

Exclusion Criteria

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
* History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 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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Klas Malmberg, MD, PhD Prof

Role: STUDY_DIRECTOR

AstraZeneca R&D Mölndal

Mark Yen, MD

Role: PRINCIPAL_INVESTIGATOR

California Clinical Trials

Locations

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Research Site

Glendale, California, United States

Site Status

Countries

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United States

References

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Ericsson H, Roshammar D, Wollbratt M, Heijer M, Persson M, Ueda S, Leonsson-Zachrisson M, Norjavaara E. Tolerability, pharmacokinetics, and pharmacodynamics of the glucokinase activator AZD1656, after single ascending doses in healthy subjects during euglycemic clamp. Int J Clin Pharmacol Ther. 2012 Nov;50(11):765-77. doi: 10.5414/CP201747.

Reference Type DERIVED
PMID: 22943931 (View on PubMed)

Other Identifiers

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D1020C00003

Identifier Type: -

Identifier Source: org_study_id