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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711074
• Other study ID #: D1710C00010
• Secondary ID: 2008-001528-30 (
• Status: Completed
• Phase: Phase 1
• First received: July 3, 2008
• Last updated: April 8, 2009
• Start date: June 2008
• Est. completion date: July 2008

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• AZD5672
single dose 200mg aqueous solution

Locations

Country	Name	City	State
United Kingdom	Research Site	Macclesfield	Cheshire

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Additional metabolite identification		0.5h, 3h, 6h, 12h, 24h	No
Secondary	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	Yes