AZD1386 Japanese Multiple Ascending Dosing Study

AstraZeneca32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Pain

Interventions

AZD1386DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: All assessments are made at each visit during the study.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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