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

December 3, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AZD5122 oral suspension (part A and B)
Drug: AZD5122
A single dose of oral suspension
Drug: AZD5122
A single intravenous infusion
Placebo Comparator: 2
Placebo oral suspension (part A)
Drug: Placebo
A single dose of oral suspension
Experimental: 3
AZD5122 oral and IV infusion (part B)
Drug: AZD5122
A single dose of oral suspension
Drug: AZD5122
A single intravenous infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
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.
Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
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.
Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Andrew Sparrow, BSc, BMedSci, BM,BS, AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

September 24, 2009

First Posted (Estimate)

September 25, 2009

Study Record Updates

Last Update Posted (Estimate)

December 4, 2009

Last Update Submitted That Met QC Criteria

December 3, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D2650C00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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