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NCT00688831 Clinical Trial

Single Ascending Dose Study (SAD) iv Formulation

Healthy Clinical Trial

— 2006-006253-27  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00688831
Other study ID # D3190C00002
Secondary ID
Status Completed
Phase Phase 1
First received May 30, 2008
Last updated December 1, 2010
Start date January 2008
Est. completion date May 2008

Study information
Verified date December 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationSweden: Medical Products Agency
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy volunteers

- BIM 19-30 kg/m2

Exclusion Criteria:

- Potassium outside normal reference values

- ECG findings outside normal range

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AZD1305
Solution for iv infusion , single dose
• Placebo
NaCl solution for iv infusion, single dose

Locations
Country Name City State
Sweden Research Site Uppsala

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight During the study Yes
Secondary Pharmacokinetic variables During all dosing visits No
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