AZD9056 Relative Bioavailability Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00908934
First received: May 22, 2009
Last updated: July 22, 2009
Last verified: July 2009
  Purpose

The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.


Condition Intervention Phase
Healthy
Drug: AZD9056 formulation Phase III 50 mg (T)
Drug: AZD9056 formulation Phase IIb 50 mg (R)
Drug: AZD9056 formulation Phase III 200 mg (T)
Drug: AZD9056 formulation Phase IIb 200mg (R)
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, 2 Cohort, 2 Period Crossover Study to Assess the Relative Bioavailability of the Phase III to the Phase IIb Formulation of AZD9056 in Healthy Male and Female Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Relative bioavailability of AZD9056 using PK variables Cmax and AUC [ Time Frame: For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F) [ Time Frame: For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7 ] [ Designated as safety issue: No ]
  • Safety variables (adverse events, safety lab, blood pressure, pulse, ECG) [ Time Frame: Frequent sampling occasions throughout the study period ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2009
Study Completion Date: July 2009
Arms Assigned Interventions
Experimental: 1
50 or 400 mg AZD9056, Test formulation
Drug: AZD9056 formulation Phase III 50 mg (T)
Given as 50 mg tablet (T)
Drug: AZD9056 formulation Phase III 200 mg (T)
Given as 400 mg (2 x 200 mg tablet (T))
Experimental: 2
50 or 400 mg AZD9056, Reference formulation
Drug: AZD9056 formulation Phase IIb 50 mg (R)
Given as 50 mg tablet (R)
Drug: AZD9056 formulation Phase IIb 200mg (R)
Given as 400 mg (2 x 200 mg tablet (R))

  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
  • Healthy Volunteers, Females should not be of childbearing potential
  • BMI between 18 and 30 kg/m2

Exclusion Criteria:

  • Clinically significant ECG abnormality suggestive of underlying cardiovascular disease
  • A history or presence of GI, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism and excretion of drugs
  • Known or suspected drug or alcohol abuse or positive DOA test
  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: NCT00908934

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

No publications provided

ClinicalTrials.gov Identifier: NCT00908934     History of Changes
Other Study ID Numbers: D1520C00004, EudraCT Number: 2009-010554-35
Study First Received: May 22, 2009
Last Updated: July 22, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Relative Bioavailability
AZD9056

ClinicalTrials.gov processed this record on October 22, 2014