AZD9056 Relative Bioavailability Study

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00908934
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 12

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	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 Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: May 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

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))

Outcome Measures

Primary Outcome Measures

1. Relative bioavailability of AZD9056 using PK variables Cmax and AUC [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

1. Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F) [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]

2. Safety variables (adverse events, safety lab, blood pressure, pulse, ECG) [Frequent sampling occasions throughout the study period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00908934
• Other Study ID Numbers: D1520C00004; EudraCT Number: 2009-010554-35
• First Posted: May 27, 2009
• Last Update Posted: Jul 23, 2009
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: Relative Bioavailability; AZD9056

Study Results

No Results Posted as of Jul 23, 2009