Study of an Extended Release (ER) Tablet, Single and Repeated Dosing
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00689039
First received: May 30, 2008
Last updated: December 1, 2010
Last verified: December 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 16, 2013