ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00940641
Recruitment Status : Suspended (Study withdrawn prior to enrollment due to AZ business decision unrelated to safety.)
First Posted : July 16, 2009
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Absorption Distribution Metabolism Excretion Drug: AZD7325 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: 1
IV dose of AZD7325
Drug: AZD7325
IV Dose

Experimental: 2
14C oral dose of AZD7325
Drug: AZD7325
oral dose




Primary Outcome Measures :
  1. To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administration [ Time Frame: Daily ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes 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

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): 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

Responsible Party: Raj Tummala, M.D./MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00940641     History of Changes
Other Study ID Numbers: D1140C00017
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Healthy Volunteer