AZD9056 Relative Bioavailability Study

July 22, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)
Time Frame: Frequent sampling occasions throughout the study period
Frequent sampling occasions throughout the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Simon Constable, ICON Development Solutions, Manchester, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Estimate)

July 23, 2009

Last Update Submitted That Met QC Criteria

July 22, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D1520C00004
  • EudraCT Number: 2009-010554-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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