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To Study the Absorption, Distribution, Metabolism and Excretion of AZD1305

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ClinicalTrials.gov Identifier: NCT00689247
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: AZD1305 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : April 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: During all dosing visits ]

Secondary Outcome Measures :
  1. Adverse events, vital signs, ECG, laboratory variables and physical examination [ Time Frame: During the study ]


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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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)
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
AZD1305
ADME
pharmacokinetic
Absorption
distribution
metabolism
excretion