Study of an Extended Release (ER) Tablet, Single and Repeated Dosing

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689039
• Other study ID #: D3190C00004
• Secondary ID: 2006-006356-35 (
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2008
• Last updated: December 1, 2010
• Start date: April 2007
• Est. completion date: July 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Exclusion Criteria:

• ECG findings outside normal range

• Potassium outside normal reference values

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD1305
ER tablet, administered as single and repeated doses.
• Placebo
Tablet, administered as single and repeated doses.

Locations

Country	Name	City	State
Sweden	Research Site	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight		During the study	Yes
Secondary	Pharmacokinetic variables		During all dosing visits	No