AZD1386 Japanese Multiple Ascending Dosing Study

Study Overview
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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.

Official Title
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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.

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: AZD1386
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD1386<br>4 groups receiving a specified volume of the active component AZD1386 at different points of time. | Drug: AZD1386<br>* Oral admin. of doses at 11 days through a 12 days period.<br>|
| Placebo Comparator: Placebo<br>Included in each dose group | Drug: Placebo<br>* Oral admin. of doses at 11 days through a 12 days period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | All assessments are made at each visit during the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the PK profile of AZD1386 after multiple dosing by assessment of plasma concentrations. |  | Blood samples will be taken before and after study drug administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Japanese, MAD, Multiple ascending dose, Chronic pain