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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00984477

Enrollment

100

Registered

2009-09-25

Start date

2009-09-30

Completion date

2009-11-30

Last updated

2009-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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.

Interventions

DRUGAZD5122

A single dose of oral suspension

DRUGPlacebo

A single dose of oral suspension

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026