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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00689247
First received: May 30, 2008
Last updated: December 2, 2010
Last verified: December 2010
  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
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: 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 October 23, 2014