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COMPLETEDPHASE1

AZD1386 Japanese Multiple Ascending Dosing Study

A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Japanese Young and Elderly Subjects After Oral Multiple Doses.

NCT00736658•AstraZeneca

View on ClinicalTrials.gov

Summary

This is a single centre, double-blind, randomised, parallel group, placebo controlled study to assess the safety, tolerability and pharmacokinetics of AZD1386 when given as multiple doses to 32 (24 healthy young and 8 healthy elderly) Japanese subjects. For young healthy subjects (aged ≥20 to ≤45 inclusive) 3 consecutive multiple ascending dose panels are planned. For elderly healthy subjects (aged ≥65 to≤80 inclusive) 1 multiple dose panel is planned.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy Japanese males or females young (≥20 to ≤45 years inclusive) or elderly (≥65 to ≤80 years inclusive). Female subjects must be surgically sterile or post-menopausal.
•Body Mass Index (BMI) of ≥19 to ≤ 27 kg/m2 and weight of ≥45 to ≤90 kg
•Clinically normal physical findings including heart rate \> 45 bpm and laboratory values and normal resting ECG

Exclusion Criteria

•History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator
•A family history of short or long QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives
•Subjects with orthostatic hypotension defined as a decrease of ≥ 25mmHg systolic blood pressure and/or a decrease of ≥15mmHg diastolic blood pressure within 5 minutes when going from a supine to standing position
•Clinically significant illness or clinically relevant trauma within 2 weeks prior to the administration of the investigational product as judged by the investigator

Locations (1)

Research Site

Fukuoka, Japan

Key Dates

Start Date

June 1, 2008

Completion Date

September 1, 2008

Last Updated

September 30, 2009

Enrollment

ESTIMATED participants

Conditions

Chronic Pain

Interventions

AZD1386

DRUG

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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AZD1386 Japanese Multiple Ascending Dosing Study

Inclusion Criteria

Exclusion Criteria

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