Healthy, Male, Overweight
Conditions
Keywords
Safety, tolerability, PK, healthy, overweight, obese
Brief summary
The purpose of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8329 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects.
Detailed description
A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of oral AZD8329 after Administration of Multiple Ascending Doses in Abdominally Obese but otherwise Healthy Male Subjects
Interventions
DRUGAZD8329
AZD8329 Oral Solution 20mg/ml
DRUGPlacebo
Placebo AZD8329 Oral Solution
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Have a body mass index (BMI) between 27 and 35 kg/m2 and a waist circumference greater than or equal to 102cm. * Provision of signed and dated, written informed consent prior to any study specific procedures * Healthy male subjects aged =20 to =50 years with suitable veins for cannulation or repeated venepuncture
Exclusion criteria
* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate. * Fasting serum (S)-glucose =7.0 mmol/L or non-fasting S-glucose =11.1 mmol/L at screening. * Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety variables (safety 12-lead paper electrocardiograms (pECG)) | pECG at screening |
| Safety variables (clinical laboratory assessments). | Clinical labs day 1 |
| Safety variables (adverse events) | Adverse events will colletected entire study |
| Safety variables (vital signs) | vital signs every hour during day 1 |
| Safety variables (physical examination) | performed at screening |
| Safety variables (telemetry) | telemetry for 24hr. post dose day 1 |
| Safety variables (digital electrocardiograms (dECGs)) | dECG during 5min, 13 times 24 hr after dose day 1 |
| Safety variables (adverse events). | Adverse events day -1 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic 11-βHSD1 enzyme activity in adipose tissue | Information will be collected from the time of day -1 throuout the study |
| Pharmacodynamic 11-βHSD1 enzyme activity in the liver by measuring prednisolone generation | Information will be collected from day -1 to follow up |
| To assess the effect on insulin after multiple doses of AZD8329 | Information will be collected from day -2 to follow up |
| To assess the effect on glucose after multiple doses of AZD8329 | Information will be collected from day -2 to follow up |
| To assess the effect on lipid variables after multiple doses of AZD8329 | Information will be collected from day -2 to follow up |
| Pharmacokinetics Plasma and urine concentrations of AZD8329 and plasma and urine pharmacokinetics parameters | Information will be collected during day -1, day 1, 2, 3 and 12 |
Countries
United Kingdom
Outcome results
None listed