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AZD1386 Japanese Multiple Ascending Dosing Study

NCT ID: NCT00736658

Last Updated: 2009-09-30

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Keywords

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Japanese MAD Multiple ascending dose Chronic pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD1386

4 groups receiving a specified volume of the active component AZD1386 at different points of time.

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

Oral admin. of doses at 11 days through a 12 days period.

Placebo

Included in each dose group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral admin. of doses at 11 days through a 12 days period.

Interventions

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AZD1386

Oral admin. of doses at 11 days through a 12 days period.

Intervention Type DRUG

Placebo

Oral admin. of doses at 11 days through a 12 days period.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Södertälje

Principal Investigators

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Rolf Karlsten

Role: STUDY_DIRECTOR

Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden

Shunji Matsuki

Role: PRINCIPAL_INVESTIGATOR

Kyusyu Clinical Phramacology Research Clinic

Locations

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Research Site

Fukuoka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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D5090C00012

Identifier Type: -

Identifier Source: org_study_id