Rheumatoid Arthritis
Conditions
Keywords
pharmacokinetics, mass balance, radiolabel, AZD5672
Brief summary
The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.
Interventions
DRUGAZD5672
single dose 200mg aqueous solution
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
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
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total radioactivity in plasma, whole blood, faeces and urine. | 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 |
| Additional metabolite identification | 0.5h, 3h, 6h, 12h, 24h |
Secondary
| Measure | Time frame |
|---|---|
| general safety assessments: AE reporting, physical examination, ECG, safety haematology and clinical chemistry assessment, vital signs | Screening, pre-dose, Visit 2 (residential period) and visit 3 follow up |
Countries
United Kingdom
Outcome results
None listed