Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01332903

First received: March 8, 2011

Last updated: July 6, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 8, 2011

Last Updated Date

July 6, 2011

Start Date ^ICMJE

May 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood [ Time Frame: From pre-dose until 168 hours post last dose ] [ Designated as safety issue: No ]
To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood and the resulting area under the concentration-time curve from zero extrapolated to infinity (AUC), to the last measurable concentration (AUC(0 t)).
To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring Plasma [14C] AZD5069:AZD5069 (cold) ratios for concentrations and selected pharmacokinetic parameters (AUCs and Cmax). [ Time Frame: From pre-dose until 168hours post last dose ] [ Designated as safety issue: No ]
To investigate the excretion of AZD5069 in human subjects by measuring the amount and percentage of radioactive dose recovered in urine, faeces, and renal clearance. [ Time Frame: From pre-dose until 168hours post last dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01332903 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To investigate the safety and tolerability of AZD5069 given orally [ Time Frame: From screening visit, Day 12, up to follow up visit ] [ Designated as safety issue: Yes ]

Assessments will include adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis and physical examination. Absolute values and change in baseline for any of these parameters will be reported.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069

Official Title ^ICMJE

A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion Following a Single Oral Dose of [14C]AZD5069 in Healthy Male Volunteers

Brief Summary

This is a phase I, open label, healthy volunteers, ADME study with single oral administration of [14C] AZD5069.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: [14C] AZD5069

Single 120 mg oral dose administered on Day 1

Study Arm (s)

Experimental: 1

[14C] AZD5069

Intervention: Drug: [14C] AZD5069

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
Regular daily bowel movements (ie, production of at least 1 stool per day).
Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1
Healthy Male volunteers aged 50 and over

Exclusion Criteria:

Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of >5 mSv in the last year, >10 mSv in the last 5 years, or a cumulative total of >1 mSv per year of life
Participation in any prior radiolabelled study within last 5 years
History of alcohol abuse or excessive intake of alcohol as judged by the investigator.

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01332903

Other Study ID Numbers ^ICMJE

D3550C00013

Has Data Monitoring Committee

Not Provided

Responsible Party

AstraZeneca, Clinical Study Information

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Prof. Tim Mant, FRCP, FFPM

Quintiles Drug Research Unit at Guy's Hospital

Information Provided By

AstraZeneca

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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