Assess the Absorption, Distribution, Metabolism and Excretion of AZD7325 After Intravenous and Oral Administration

This study has suspended participant recruitment.
(Study withdrawn prior to enrollment due to AZ business decision unrelated to safety.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00940641
First received: July 15, 2009
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to evaluate the absorption, distribution, metabolism and excretion of AZD7325 after intravenous and 14C labeled oral dose


Condition Intervention Phase
Absorption
Distribution
Metabolism
Excretion
Drug: AZD7325
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1, Open, Two Period, Single-Centre, Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) After Intravenous and 14C-labelled Oral Administration of AZD7325 to Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administration [ Time Frame: Daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate safety and tolerability after a single oral administration of [14C] AZD7325 and after a single intravenous administration of non radio-labelled AZD7325 [ Time Frame: Daily ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: August 2009
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
IV dose of AZD7325
Drug: AZD7325
IV Dose
Experimental: 2
14C oral dose of AZD7325
Drug: AZD7325
oral dose

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects Day 1
  • Body Mass Index (BMI) > 18 and < 30kg/m2

Exclusion Criteria:

  • Clinically relevant disease and abnormalities (past or present) which in the opinion of the investigator, may either put the subject at risk to participate in this study or may influence the results of the study or the subject's ability to participate in the study
  • Use of prescription medication within 14 days of the first dose of the investigational product
  • Blood loss in excess of 200 mL within 30 days of Day-1 in excess of 500 mL within 90 days of Day-1 or in excess of 1350 mL within 1 year of Day-1 or donation of blood products within 14 days of Day -1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940641

Locations
United Kingdom
Research Site
Alderley Park, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Raj Chetty, MBBS, MD, FRCPath. AstraZeneca Alderly Park CPU
  More Information

No publications provided

Responsible Party: Raj Tummala, M.D./MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00940641     History of Changes
Other Study ID Numbers: D1140C00017
Study First Received: July 15, 2009
Last Updated: January 21, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Healthy Volunteer

ClinicalTrials.gov processed this record on April 23, 2014