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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Safety variables (adverse events).
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
1
Intervention: Placebo (Drug)
2
AZD8329
Intervention: AZD8329 (Drug)
Outcomes
Primary Outcomes
Safety variables (adverse events).
Time Frame: Adverse events will colletected entire study
Safety variables (clinical laboratory assessments).
Time Frame: clinical labs day -3
Safety variables (adverse events)
Time Frame: Adverse events will colletected entire study
Safety variables (vital signs)
Time Frame: Vital Signs every hr during day 12
Safety variables (physical examination)
Time Frame: Performed at follow up
Safety variables (telemetry)
Time Frame: telemetry for 24hr. post dose day 12
Safety variables (digital electrocardiograms (dECGs))
Time Frame: dECG during 5min, 13 times 24 hr after dose day 12
Safety variables (safety 12-lead paper electrocardiograms (pECG))
Time Frame: pECG at follow up
Secondary Outcomes
- 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)
- 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)