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
  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
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

No publications provided

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 August 28, 2014