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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00984477

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

49.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD5122 Drug: Placebo Drug: AZD5122	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official 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

Study Start Date :

Sep 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 AZD5122 oral suspension (part A and B)	Drug: AZD5122 A single dose of oral suspension
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

Arm

Intervention/Treatment

Experimental: 1

AZD5122 oral suspension (part A and B)

Drug: AZD5122

A single dose of oral suspension

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

Outcome Measures

Primary Outcome Measures

Pharmacokinetic profile: concentration of AZD5122 in blood [Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.]

Secondary Outcome Measures

Pharmacokinetic profile: concentration of AZD5122 in urine [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 [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 [Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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