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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00711074

Collaborator

(none)

Enrollment

Location

Arm

Duration (Days)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: AZD5672	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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 Start Date :

Jun 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AZD5672 single dose 200mg aqueous solution

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD5672

single dose 200mg aqueous solution

Outcome Measures

Primary Outcome Measures

total radioactivity in plasma, whole blood, faeces and urine. [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]
Additional metabolite identification [0.5h, 3h, 6h, 12h, 24h]

Secondary Outcome Measures

general safety assessments: AE reporting, physical examination, ECG, safety haematology and clinical chemistry assessment, vital signs [Screening, pre-dose, Visit 2 (residential period) and visit 3 follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)