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Completed

NCT Number: NCT00940212

Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers

The primary aim of this study is to investigate the safety and tolerability of AZD2423 single doses in healthy volunteers.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Have a body mass index (BMI) between ≥18 and ≤30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg
  • Healthy male and non-fertile female volunteers with suitable veins for cannulation or repeated venipuncture

Exclusion criteria

  • History of 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 results or the subject's ability to participate in the study
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • Any clinically significant illness/infection or medical/surgical procedure or trauma,as judged by the Principal Investigator, within 3 months of the first administration of investigational product

Treatment and study plan

AZD2423

Drug

oral, single administration

Placebo

Drug

oral administration and single dose

Primary outcomes

  1. To assess the safety and tolerability of AZD2423 following administration of single ascending doses and if possible to estimate the maximum tolerated dose (MTD), if within the predefined exposure limits.

    Time frame: 3 day residential period plus 7-10 days follow up

Secondary outcomes

  1. To characterise the pharmacokinetics of AZD2423 and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses ofAZD2423.

    Time frame: 3 day residential period plus 7-10 days follow up

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Male and Female Volunteers Without Childbearing Potential

Acronym: SAD

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 15, 2009
Registry last updated
Dec 10, 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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