AZD1386 Japanese Multiple Ascending Dosing Study (JMAD)

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Chronic Pain

Treatments

Drug: AZD1386

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00736658

D5090C00012

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

Accepts 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