Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01100047
First received: March 24, 2010
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days.


Condition Intervention Phase
Healthy
Drug: AZD5069
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 in Healthy Japanese Subjects After Single and Multiple Ascending Doses

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry [ Time Frame: From screening period to follow-up visit 42 days (Maximum) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole 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 ]
  • Measurement of the effect of AZD5069 on blood cells [ 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 ]
  • Pharmacokinetic profile: concentration of AZD5069 in blood [ Time Frame: Baselines at Visit 1 or pre-dose Day 1, assessments Visit 2, post-dose until 96hr post final dose. Follow up assessments at Visit 3. 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 ]

Enrollment: 63
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD5069
Oral suspension
Placebo Comparator: 2 Drug: Placebo
Oral suspension

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Japanese subjects with suitable veins for cannulation or repeated venepuncture.
  • Have a body mass index (BMI) between 17 and 27 kg/m2 and a body weight between 45 and 80 kg
  • Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator
  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: NCT01100047

Locations
United Kingdom
Research Site
Croydon, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ulrike Lorch, Lorch, MD MFPM FRCA Richmond Pharmacology Limited
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01100047     History of Changes
Other Study ID Numbers: D3550C00005, 2009-018185-35
Study First Received: March 24, 2010
Last Updated: March 17, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Phase I
Japanese healthy volunteer
AZD5069

ClinicalTrials.gov processed this record on August 26, 2014