AZD9056 Relative Bioavailability Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: 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)

• Registration Number: NCT00908934
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Status Verified: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-22
• Last Update Posted: 2009-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD9056 formulation Phase III 50 mg (T)	50 or 400 mg AZD9056, Test formulation
1	AZD9056 formulation Phase III 200 mg (T)	50 or 400 mg AZD9056, Test formulation
2	AZD9056 formulation Phase IIb 50 mg (R)	50 or 400 mg AZD9056, Reference formulation
2	AZD9056 formulation Phase IIb 200mg (R)	50 or 400 mg AZD9056, Reference formulation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)	Frequent sampling occasions throughout the study period

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom