Pain
Conditions
Keywords
Pain
Brief summary
The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.
Interventions
DRUGAZD1386
1 dose of oral solution
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index of 18 - 30 and weight of 50 to 100 kilos. * Healthy volunteer must have regular bowel movements (at least once daily)
Exclusion criteria
* History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator. * A family history of short QT syndrome or sudden cardiac death amongst first degree relatives. * Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386 | Until >90% of predicted total radioactivity has been recovered |
| Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta | Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h |
Secondary
| Measure | Time frame |
|---|---|
| AZD1386 metabolites in plasma+excreta if feasable | Predose, 1h, 4h, 8h 24h |
| Safety + tolerability of AZD1386 | Predose, 2h, 6h, 12h, 24h, 48h, 168h |
Countries
United Kingdom
Outcome results
None listed