Status:
COMPLETED
AZD1386 Japanese Multiple Ascending Dosing Study
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Pain
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
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 he...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00736658
Start Date
June 1 2008
End Date
September 1 2008
Last Update
September 30 2009
Active Locations (1)
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1
Research Site
Fukuoka, Japan