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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: AZD5672

Study type: Interventional

Funder types: Industry

Identifiers

NCT00711074

2008-001528-30 (EUdract No)

D1710C00010

Details and patient eligibility

About

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

Enrollment: 4 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

1

Experimental group

Treatment:

Drug: AZD5672