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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD5122; Drug: Placebo

• Registration Number: NCT00984477
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Study Completion: 2009-11
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-03
• Last Update Posted: 2009-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	AZD5122	AZD5122 oral and IV infusion (part B)
2	Placebo	Placebo oral suspension (part A)
1	AZD5122	AZD5122 oral suspension (part A and B)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Nottinghamshire, United Kingdom