Status:
TERMINATED
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmakodynamics of AZD2820 After Multiple Ascending Doses
Lead Sponsor:
AstraZeneca
Conditions:
Obesity
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This is a randomised and single-blind, placebo-controlled study to investigate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of repeated and ascending doses of AZD2820 to obese but ot...
Detailed Description
A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2820 after Administration ...
Eligibility Criteria
Inclusion
- Provision of signed and dated, written informed consent prior to any study specific procedures including the genetic sampling and analyses
- Obese but otherwise healthy male subjects aged 18 - 45 years with suitable veins for cannulation or repeated venepuncture
- Male subjects should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after the last dose of investigational product
- Have a body mass index (BMI) between 27 and 40 kg/m2
Exclusion
- 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 in the stud
- A history of erectile dysfunction or anatomic abnormality of the penis (eg, cavernosal fibrosis, Peyronie's disease, or plaques) which interferes with normal erectile function
- Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2820
- Any clinically significant abnormalities in clinical chemistry, haematology (including eosinophilia) or urinalysis results as judged by the investigator
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01469923
Start Date
March 1 2012
End Date
December 1 2012
Last Update
July 24 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research site
London, United Kingdom