To Study the Absorption, Distribution, Metabolism and Excretion of AZD1305
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00689247
First received: May 30, 2008
Last updated: December 2, 2010
Last verified: December 2010
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Purpose
The purpose of this study is to learn more about how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion of AZD1305.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: AZD1305 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Open, Randomised, Single-Centre, Crossover Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) After Oral and Intravenous Administration of 14C-labelled and Non-labelled AZD1305 to Healthy Male Volunteers |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Pharmacokinetic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events, vital signs, ECG, laboratory variables and physical examination [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
| Enrollment: | 10 |
| Study Start Date: | April 2008 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
AZD1305 given as oral solution
|
Drug: AZD1305
oral solution, single dose
|
|
Experimental: B
AZD1305 given as iv infusion
|
Drug: AZD1305
iv infusion, single dose
|
Eligibility| Ages Eligible for Study: | 35 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy volunteers
- A body mass index (BMI=weight/height2) of 19 to 30 kg/m2
Exclusion Criteria:
- Potassium outside normal reference values
- ECG findings outside normal range
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689247
Locations
| United Kingdom | |
| Research Site | |
| Macclesfield, Cheshire, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Helen Lunde, MD | AstraZeneca R&D Mölndal, Sweden |
| Principal Investigator: | Raj Chetty, MBBS, MD | AstraZeneca CPU Alderley Park, United Kingdom |
More Information
No publications provided
| Responsible Party: | Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00689247 History of Changes |
| Other Study ID Numbers: | D3190C00008, 2007-007784-25 (EudraCT No) |
| Study First Received: | May 30, 2008 |
| Last Updated: | December 2, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by AstraZeneca:
|
AZD1305 ADME pharmacokinetic Absorption |
distribution metabolism excretion |
ClinicalTrials.gov processed this record on May 21, 2013