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Completed

NCT Number: NCT00711074

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Macclesfield, Cheshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AZD5672

Drug

single dose 200mg aqueous solution

Primary outcomes

  1. 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

  2. Additional metabolite identification

    Time frame: 0.5h, 3h, 6h, 12h, 24h

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Study completion
2008
First posted
Jul 8, 2008
Registry last updated
Apr 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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