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
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
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014