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Clinical Trials/NCT00738322
NCT00738322
Completed
Phase 1

A Single-Centre, Single-Blind, Randomised, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD1305 in Healthy Male Japanese Subjects

AstraZeneca1 site in 1 country36 target enrollmentJuly 2008
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ConditionsHealthy
InterventionsAZD1305Placebo
DrugsAZD1305Placebo

Overview

Phase
Phase 1
Intervention
AZD1305
Conditions
Healthy
Sponsor
AstraZeneca
Enrollment
36
Locations
1
Primary Endpoint
Safety by assessment of adverse events, ECG variables, BP, pulse rate, physical examination, laboratory variables, body temperature and body weight
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
October 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Eligibility Criteria

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.

Arms & Interventions

1

Intervention: AZD1305

2

Intervention: Placebo

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(During the dosing visits)

Study Sites (1)

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