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SuspendedNCT00940641Updated Jan 24, 2011

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

A Phase 1 interventional study of AZD7325 and AZD7325 in Absorption, Distribution and Metabolism, sponsored by AstraZeneca. Suspended at 1 site in United Kingdom. Open to male participants aged 35 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-24.

Sponsored by AstraZeneca · Phase 1 and Interventional

Why this study was suspended
Study withdrawn prior to enrollment due to AZ business decision unrelated to safety.
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
35 Years to 50 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Absorption
  • Distribution
  • Metabolism
  • Excretion

Keywords

  • Healthy Volunteer
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    1

    IV dose of AZD7325

    Drug: AZD7325

  • Experimental
    2

    14C oral dose of AZD7325

    Drug: AZD7325

Interventions

  • DrugAZD7325

    IV Dose

  • DrugAZD7325

    oral dose

06

What researchers measure

Primary outcomes

  1. To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administration

    Time frame: Daily

Secondary outcomes

  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

07

Study locations

1 site
  • Research Site
    Alderley Park, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00940641
Lead sponsor
AstraZeneca
First posted
Jul 16, 2009
Start date
Aug 2009
Primary completion
Oct 2009 (estimated)
Completion
Oct 2009 (estimated)
Last update
Jan 24, 2011

Study contacts

Raj Chetty, MBBS, MD, FRCPath.
principal investigator · AstraZeneca Alderly Park CPU

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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