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OpenTrials
Completed

NCT Number: NCT00688831

Single Ascending Dose Study (SAD) iv Formulation

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

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers
  • BIM 19-30 kg/m2

Exclusion criteria

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

Treatment and study plan

AZD1305

Drug

Solution for iv infusion , single dose

Placebo

Drug

NaCl solution for iv infusion, single dose

Primary outcomes

  1. Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight

    Time frame: During the study

Secondary outcomes

  1. Pharmacokinetic variables

    Time frame: During all dosing visits

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: 2006-006253-27

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 3, 2008
Registry last updated
Dec 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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