To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of AZD8329 (AZ8329)

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy

Overweight

Male

Treatments

Drug: Placebo

Drug: AZD8329

Study type

Interventional

Funder types

Industry

Identifiers

NCT01207089

D2350C00010

Details and patient eligibility

About

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.

Full 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

Enrollment

45 estimated patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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