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

History of Changes

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

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 May 23, 2013

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