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CompletedNCT00711074Updated Apr 9, 2009

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

A Phase 1 interventional study of AZD5672 in Rheumatoid Arthritis, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-04-09.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
50 Years and older
Sex
Male
01

Study summary

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

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • pharmacokinetics
  • mass balance
  • radiolabel
  • AZD5672
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 4 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (estimated)

Study arms

  • Experimental
    1

    Drug: AZD5672

Interventions

  • DrugAZD5672

    single dose 200mg aqueous solution

06

What researchers measure

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

07

Study locations

1 site
  • Research Site
    Macclesfield, Cheshire, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00711074
Lead sponsor
AstraZeneca
First posted
Jul 8, 2008
Start date
Jun 2008
Completion
Jul 2008
Last update
Apr 9, 2009

Study contacts

Mark Layton
study director · AstraZeneca
Raj Chetty
principal investigator · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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