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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00711074
First received: July 3, 2008
Last updated: April 8, 2009
Last verified: April 2009
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 4
Study Start Date: June 2008
Study Completion Date: July 2008
Arms Assigned Interventions
Experimental: 1 Drug: AZD5672
single dose 200mg aqueous solution

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
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: Mark Layton, MD, MRCP(UK), MFPM, Medical Science Director, Early Development RITA, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00711074     History of Changes
Other Study ID Numbers: D1710C00010, 2008-001528-30 (EUdract No)
Study First Received: July 3, 2008
Last Updated: April 8, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
pharmacokinetics
mass balance
radiolabel
AZD5672

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014