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

Phase 1CompletedNCT01207089

AstraZeneca45 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Overweight Healthy Male

Interventions

AZD8329DRUG

AZD8329 Oral Solution 20mg/ml

PlaceboDRUG

Placebo AZD8329 Oral Solution

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

Safety variables (adverse events).

Time frame: Adverse events day -1

Safety variables (adverse events).

Time frame: Adverse events will colletected entire study