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Completed

NCT Number: NCT01100047

Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069

This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days.

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Croydon, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Japanese subjects with suitable veins for cannulation or repeated venepuncture.
  • Have a body mass index (BMI) between 17 and 27 kg/m2 and a body weight between 45 and 80 kg
  • Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

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 4 weeks of the first administration of investigational product.
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator

Treatment and study plan

AZD5069

Drug

Oral suspension

Placebo

Drug

Oral suspension

Primary outcomes

  1. Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry

    Time frame: From screening period to follow-up visit 42 days (Maximum)

Secondary outcomes

  1. Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood

    Time frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose

  2. Measurement of the effect of AZD5069 on blood cells

    Time frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose

  3. Pharmacokinetic profile: concentration of AZD5069 in blood

    Time frame: Baselines at Visit 1 or pre-dose Day 1, assessments Visit 2, post-dose until 96hr post final dose. Follow up assessments at Visit 3. Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 in Healthy Japanese Subjects After Single and Multiple Ascending Doses

Acronym: JSMAD

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 8, 2010
Registry last updated
Jun 25, 2015

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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