Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: [14C] AZD5069
- Registration Number
- NCT01332903
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a phase I, open label, healthy volunteers, ADME study with single oral administration of \[14C\] AZD5069.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
- Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
- Regular daily bowel movements (ie, production of at least 1 stool per day).
- Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1
- Healthy Male volunteers aged 50 and over
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 in the last 5 years, or a cumulative total of >1 mSv per year of life
- Participation in any prior radiolabelled study within last 5 years
- History of alcohol abuse or excessive intake of alcohol as judged by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 [14C] AZD5069 \[14C\] AZD5069
- Primary Outcome Measures
Name Time Method To investigate the excretion of AZD5069 in human subjects by measuring the amount and percentage of radioactive dose recovered in urine, faeces, and renal clearance. From pre-dose until 168hours post last dose To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood From pre-dose until 168 hours post last dose To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of \[14C\] radioactivity in plasma and whole blood and the resulting area under the concentration-time curve from zero extrapolated to infinity (AUC), to the last measurable concentration (AUC(0 t)).
To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring Plasma [14C] AZD5069:AZD5069 (cold) ratios for concentrations and selected pharmacokinetic parameters (AUCs and Cmax). From pre-dose until 168hours post last dose
- Secondary Outcome Measures
Name Time Method To investigate the safety and tolerability of AZD5069 given orally From screening visit, Day 12, up to follow up visit Assessments will include adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis and physical examination. Absolute values and change in baseline for any of these parameters will be reported.
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom