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

Metabolism Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00940641
• Other study ID #: D1140C00017
• Status: Suspended
• Phase: Phase 1
• First received: July 15, 2009
• Last updated: January 21, 2011
• Start date: August 2009
• Est. completion date: October 2009

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 8
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Absorption
• Distribution
• Excretion
• Metabolism

Intervention

Drug:
• AZD7325
IV Dose
• AZD7325
oral dose

Locations

Country	Name	City	State
United Kingdom	Research Site	Alderley Park

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administration		Daily	No
Secondary	To evaluate safety and tolerability after a single oral administration of [14C] AZD7325 and after a single intravenous administration of non radio-labelled AZD7325		Daily	No