To Study Safety, Tolerability and Pharmacokinetics of AZD1305 in Healthy Male Japanese Subjects

AstraZeneca36 enrolled

Overview

The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body ( how it is taken up into the body, distributed around the body and disappears from the body) in healthy Japanese males.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

AZD1305DRUG

Solution for iv infusion, single dose

PlaceboDRUG

NaCl solution for iv infusion, single dose

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * A body mass index (BMI=weight/height2) of 19 to 27 kg/m2 * Japanese males Exclusion Criteria: * ECG findings outside normal reference ranges. * Potassium outside normal reference ranges.

Locations (1)

Research Site

Fukuoka, Japan

Outcomes

Primary Outcomes

Safety by assessment of adverse events, ECG variables, BP, pulse rate, physical examination, laboratory variables, body temperature and body weight

Time frame: During the study

Secondary Outcomes

Pharmacokinetic variables

Time frame: During the dosing visits

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.