AZD1386 Japanese Multiple Ascending Dosing Study

Phase 1

Completed

• Conditions: Chronic Pain
• Interventions: Drug: AZD1386; Drug: Placebo

• Registration Number: NCT00736658
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Study Completion: 2008-09
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-29
• Last Update Posted: 2009-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD1386	AZD1386	4 groups receiving a specified volume of the active component AZD1386 at different points of time.
Placebo	Placebo	Included in each dose group

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Fukuoka, Japan