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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00984477
First received: September 24, 2009
Last updated: December 3, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Healthy
Drug: AZD5122
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2009
Study Completion Date: November 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984477

Locations
United Kingdom
Research Site
Nottinghamshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Andrew Sparrow, BSc, BMedSci, BM,BS AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00984477     History of Changes
Other Study ID Numbers: D2650C00006
Study First Received: September 24, 2009
Last Updated: December 3, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Healthy volunteer
healthy subjects
AZD5122
single oral dose
phase 1
Healthy volunteer phase 1 study

ClinicalTrials.gov processed this record on October 19, 2014