NCT00688831
Completed
Phase 1
A Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Ascending Intravenous Doses of AZD1305 in Helahty Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- AZD1305
- Conditions
- Healthy
- Sponsor
- AstraZeneca
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight
- Status
- Completed
- Last Updated
- 15 years ago
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers
- •BIM 19-30 kg/m2
Exclusion Criteria
- •Potassium outside normal reference values
- •ECG findings outside normal range
Arms & Interventions
A
AZD1305 solution for iv infusion
Intervention: AZD1305
B
NaCl solution for iv infusion
Intervention: Placebo
Outcomes
Primary Outcomes
Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight
Time Frame: During the study
Secondary Outcomes
- Pharmacokinetic variables(During all dosing visits)
Study Sites (1)
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