A Two-part, Single-centre, Open (Part A) Single Blind (Part B), Randomised, Placebo-controlled Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Doses With and Without Food and Multiple Ascending Oral Doses of AZD1305 Extended-release Tablet in Healthy & Elderly Subj

AstraZeneca1 site in 1 country94 target enrollmentApril 2007

ConditionsHealthy

InterventionsAZD1305 Placebo

DrugsAZD1305 Placebo

Overview

Phase: Phase 1
Intervention: AZD1305
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 94
Locations: 1
Primary Endpoint: Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.

Registry

clinicaltrials.gov

Start Date

April 2007

End Date

July 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
•Clinically normal physical findings, laboratory values and resting ECG as judged by the investigator