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

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

Status
Suspended
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00940641
Enrollment
8
Registered
2009-07-16
Start date
2009-08-31
Completion date
2009-10-31
Last updated
2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Absorption, Distribution, Excretion, Metabolism

Keywords

Healthy Volunteer

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

Interventions

IV Dose

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
35 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administrationDaily

Secondary

MeasureTime frame
To evaluate safety and tolerability after a single oral administration of [14C] AZD7325 and after a single intravenous administration of non radio-labelled AZD7325Daily

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026