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AZD1386 Japanese Multiple Ascending Dosing Study (JMAD)

Primary Purpose

Chronic Pain

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

AZD1386

Placebo

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Japanese, MAD, Multiple ascending dose, Chronic pain

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AZD1386

Placebo

Arm Description

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

Included in each dose group

Outcomes

Primary Outcome Measures

To investigate the safety and tolerability of AZD1386 after multiple dosing in young and elderly healthy Japanese subjects by assessment of adverse events, vital signs, ECG parameters, body temperature, clinical chemistry, haematology and urinalysis.

Secondary Outcome Measures

To determine the PK profile of AZD1386 after multiple dosing by assessment of plasma concentrations.

Full Information

NCT ID

NCT00736658

First Posted

August 15, 2008

Last Updated

September 29, 2009

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00736658

Brief Title

AZD1386 Japanese Multiple Ascending Dosing Study

Acronym

JMAD

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

Japanese, MAD, Multiple ascending dose, Chronic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AZD1386

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Included in each dose group

Intervention Type

Drug

Intervention Name(s)

AZD1386

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

All assessments are made at each visit during the study.

Secondary Outcome Measure Information:

Title

To determine the PK profile of AZD1386 after multiple dosing by assessment of plasma concentrations.

Time Frame

Blood samples will be taken before and after study drug administration.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rolf Karlsten

Organizational Affiliation

Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Shunji Matsuki

Organizational Affiliation

Kyusyu Clinical Phramacology Research Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Fukuoka

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

AZD1386 Japanese Multiple Ascending Dosing Study

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