A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Caucasian Young and Elderly Subjects After Oral Multiple Doses.

AstraZeneca1 site in 1 country69 target enrollmentFebruary 2008

ConditionsChronic Pain

InterventionsAZD1386 Placebo

DrugsAZD1386 Placebo

Overview

Phase: Phase 1
Intervention: AZD1386
Conditions: Chronic Pain
Sponsor: AstraZeneca
Enrollment: 69
Locations: 1
Primary Endpoint: Safety AEs and vital signs
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being performed in order to learn more about the safety and tolerability of AZD1386. AZD1386 is primary intended for treatment of chronic pain.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

October 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Healthy Caucasians, males or females aged ≥20 and ≤ 45 years or between 65 80 years. Female subjects must be surgically sterile or post-menopausal for at least 12 months prior to the enrolment visit.
•Body Mass Index (BMI) of ≥18 to ≤ 30 kg/m2 and weight of ≥50 to ≤100 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.
•History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity.
•Subjects with a high decrease in blood pressure within 5 minutes when going from a supine to standing position.