AZD1386 Japanese Multiple Ascending Dosing Study

Chronic Pain Clinical Trial

— JMAD  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736658
• Other study ID #: D5090C00012
• Status: Completed
• Phase: Phase 1
• First received: August 15, 2008
• Last updated: September 29, 2009
• Start date: June 2008
• Est. completion date: September 2008

Study information

• Verified date: September 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• AZD1386
Oral admin. of doses at 11 days through a 12 days period.
• Placebo
Oral admin. of doses at 11 days through a 12 days period.

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	No