AZD5672 Bioavailability Study in Healthy Male and Female Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00871767
First received: March 26, 2009
Last updated: June 29, 2009
Last verified: June 2009
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: March 26, 2009
Last Updated: June 29, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014