Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00711074

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: AZD5672	Phase I

MedlinePlus related topics: Rheumatoid Arthritis

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment, Pharmacokinetics Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Additional metabolite identification [ Time Frame: 0.5h, 3h, 6h, 12h, 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Arms	Assigned Interventions
1: Experimental	Drug: AZD5672 single dose 200mg aqueous solution

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711074

Locations

United Kingdom, Cheshire
Research Site
Macclesfield, Cheshire, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Mark Layton	AstraZeneca
Principal Investigator:	Raj Chetty	AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Mark Layton, MD, MRCP(UK), MFPM, Medical Science Director, Early Development RITA )
Study ID Numbers:	D1710C00010, 2008-001528-30 (EUdract No)
Study First Received:	July 3, 2008
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00711074 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

pharmacokinetics
mass balance
radiolabel
AZD5672

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Healthy
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009