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Completed

NCT Number: NCT00984477

Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male Subjects

The purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by the body when given to healthy, non smoking males at different dose levels. This is a 2 part study, in Part B a single group of subjects will be given both an oral dose and intravenous microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Nottinghamshire, United Kingdom

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.
  • Normal physical examination, laboratory values, blood pressure and pulse
  • Healthy male caucasian subjects

Exclusion criteria

  • Subjects must not have any history of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body.
  • Subjects must not have abnormal blood or urine tests for hsCRP, circulating neutrophils, haematocrit, haemoglobin or renal function
  • Subjects must not have crystals or more than a trace of blood in their urine

Treatment and study plan

AZD5122

Drug

A single dose of oral suspension

Placebo

Drug

A single dose of oral suspension

Primary outcomes

  1. Pharmacokinetic profile: concentration of AZD5122 in blood

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

Secondary outcomes

  1. Pharmacokinetic profile: concentration of AZD5122 in urine

    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 AZD5122 on circulating neutrophils

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

  3. Pharmacodynamic profile: assessment of various pharmacodynamic measures

    Time frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Exploratory Study to Assess the Pharmacokinetics of Single Oral Doses and a Single Intravenous Radiolabelled Microtracer Dose of AZD5122 in Healthy Male Subjects

Important dates

Study start
2009
Study completion
2009
First posted
Sep 25, 2009
Registry last updated
Dec 4, 2009

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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