Study of an Extended Release (ER) Tablet, Single and Repeated Dosing - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00689039

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: AZD1305 Drug: Placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: No ]

Enrollment:	94
Study Start Date:	April 2007
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental AZD1305 ER tablet	Drug: AZD1305 ER tablet, administered as single and repeated doses.
B: Placebo Comparator Placebo tablet	Drug: Placebo Tablet, administered as single and repeated doses.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Exclusion Criteria:

ECG findings outside normal range
Potassium outside normal reference values

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689039

Locations

Sweden
Research Site
GÖTEBORG, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Helen Lunde, MD	AstraZeneca R&D Mölndal, Sweden
Principal Investigator:	Marianne Hartford, MD, PhD	AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden

More Information

Responsible Party:	AstraZeneca ( Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids )
Study ID Numbers:	D3190C00004, 2006-006356-35 (EudraCT No)
Study First Received:	May 30, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00689039
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

AZD1305
safety
pharmacokinetics
multiple ascending doses
Safety and pharmacokinetics

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009