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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: AZD5672

• Registration Number: NCT00711074
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study Completion: 2008-07
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-08
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-08
• Last Update Posted: 2009-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD5672	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Macclesfield, Cheshire, United Kingdom