Text Size

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
History of Changes
  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:

U.S. FDA Resources

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 May 21, 2013