AZD5672 Bioavailability Study in Healthy Male and Female Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00871767
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : June 30, 2009
Information provided by:

Brief Summary:
The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: AZD5672 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects
Study Start Date : March 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
40 or 100mg AZD5672, Reference formulation
Drug: AZD5672
40 mg tablet (Reference formulation)

Drug: AZD5672
100 mg (2 x 50 mg tablet (Reference Formulation)

Experimental: 2
40 or 100mg AZD5672, Test formulation
Drug: AZD5672
40 mg tablet (Test formulation)

Drug: AZD5672
100 mg tablet (Test formulation)

Primary Outcome Measures :
  1. Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss [ Time Frame: Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28 ]

Secondary Outcome Measures :
  1. Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: AE assessed throughout whole the study, twice weekly assessment of BP, pulse and safety labs throughout study period ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Provision of informed consent prior to any study-specific procedures
  • BMI between 18 and 30 kg/m2
  • Medical and surgical history and physical examination without any clinically significant findings
  • Non smokers or past smokers who have stopped smoking within the last 6 months.

Exclusion Criteria:

  • History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
  • Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product.
  • Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00871767

United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
Study Chair: Mark Layton AstraZeneca R&D, Alderley Park, UK
Principal Investigator: Simon Constable ICON Development Solutions, Manchester, UK

Responsible Party: Mark Layton, MD, PhD, Medical Science Director, AstraZeneca Identifier: NCT00871767     History of Changes
Other Study ID Numbers: D1710C00019
EudraCt No. 2009-009423-10
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
relative bioavailability
rheumatoid arthritis (RA)

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents