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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00689039

First received: May 30, 2008

Last updated: December 1, 2010

Last verified: December 2010

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
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:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	20 Years to 70 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:	Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00689039 History of Changes
Other Study ID Numbers:	D3190C00004 2006-006356-35 (EudraCT No)
Study First Received:	May 30, 2008
Last Updated:	December 1, 2010
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:


AZD1305 safety pharmacokinetics multiple ascending doses Safety and pharmacokinetics

ClinicalTrials.gov processed this record on September 29, 2016

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