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Completed

NCT Number: NCT00935662

A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses

The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.

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Key information

Conditions

Healthy Men

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Linköping, Sweden

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of informed consent prior to any study specific procedures
  • Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

Exclusion criteria

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Treatment and study plan

AZD8329

Drug

Oral solution, single ascending doses

Placebo

Drug

Oral solution, placebo

Primary outcomes

  1. Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)

    Time frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.

Secondary outcomes

  1. PK samples for AZD8329

    Time frame: Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Single-blind, Placebo-controlled, Two-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD8329 After Single Ascending Oral Doses

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 9, 2009
Registry last updated
Sep 13, 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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