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AZD5672 Bioavailability Study in Healthy Male and Female Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00871767
First Posted: March 30, 2009
Last Update Posted: June 30, 2009
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Rheumatoid Arthritis Drug: AZD5672 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: March 2009
Study Completion Date: May 2009
Arms Assigned Interventions
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)

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00871767


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

Responsible Party: Mark Layton, MD, PhD, Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00871767     History of Changes
Other Study ID Numbers: D1710C00019
EudraCt No. 2009-009423-10
First Submitted: March 26, 2009
First Posted: March 30, 2009
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
AZD5672
relative bioavailability
rheumatoid arthritis (RA)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents