Single Ascending Dose Study (SAD) iv Formulation

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: AZD1305

• Registration Number: NCT00688831
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-01
• Last Update Posted: 2010-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Healthy volunteers
• BIM 19-30 kg/m2

Exclusion Criteria

• Potassium outside normal reference values
• ECG findings outside normal range

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	NaCl solution for iv infusion
A	AZD1305	AZD1305 solution for iv infusion

Primary Outcome Measures

Name	Time	Method
Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight	During the study

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic variables	During all dosing visits

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden