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Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

AZD5672

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring pharmacokinetics, mass balance, radiolabel, AZD5672

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Body Mass index (BMI) 18-30 kg/m2, inclusive.
Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology & urinalysis, as judged by the investigator

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 over the last 5 years or a cumulative total of >1 mSv per year of life
Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator
Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

total radioactivity in plasma, whole blood, faeces and urine.

Additional metabolite identification

Secondary Outcome Measures

general safety assessments: AE reporting, physical examination, ECG, safety haematology and clinical chemistry assessment, vital signs

Full Information

NCT ID

NCT00711074

First Posted

July 3, 2008

Last Updated

April 8, 2009

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00711074

Brief Title

Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

Official Title

An Open-Label, Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of [14C]AZD5672 in Healthy Male Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

pharmacokinetics, mass balance, radiolabel, AZD5672

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AZD5672

Intervention Description

single dose 200mg aqueous solution

Primary Outcome Measure Information:

Title

total radioactivity in plasma, whole blood, faeces and urine.

Time Frame

Pre-dose, post dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240h

Title

Additional metabolite identification

Time Frame

0.5h, 3h, 6h, 12h, 24h

Secondary Outcome Measure Information:

Title

general safety assessments: AE reporting, physical examination, ECG, safety haematology and clinical chemistry assessment, vital signs

Time Frame

Screening, pre-dose, Visit 2 (residential period) and visit 3 follow up

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Body Mass index (BMI) 18-30 kg/m2, inclusive. Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology & urinalysis, as judged by the investigator 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 over the last 5 years or a cumulative total of >1 mSv per year of life Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Layton

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Raj Chetty

Organizational Affiliation

AstraZeneca

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Macclesfield

State/Province

Cheshire

Country

United Kingdom

12. IPD Sharing Statement

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Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

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