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

NCT00984477 | Completed Phase 1

• 1 other identifier: D2650C00006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy volunteer; healthy subjects; AZD5122; single oral dose; phase 1; Healthy volunteer phase 1 study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (3)

1

EXPERIMENTAL

AZD5122 oral suspension (part A and B)

Drug: AZD5122

2

PLACEBO COMPARATOR

Placebo oral suspension (part A)

Drug: Placebo

3

EXPERIMENTAL

AZD5122 oral and IV infusion (part B)

Drug: AZD5122

Interventions

AZD5122 DRUG

A single dose of oral suspension

1; 3

Placebo DRUG

A single dose of oral suspension

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated, written informed consent.
• Normal physical examination, laboratory values, blood pressure and pulse
• Healthy male caucasian subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Nottinghamshire, United Kingdom

Location

MeSH Terms

Interventions

AZD5122

Study Officials

• Andrew Sparrow, BSc, BMedSci, BM,BS

  AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 4, 2009

Record last verified: 2009-12

Locations

GB (1)