AZD9056 Relative Bioavailability Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD9056 formulation Phase IIb 200mg (R); Drug: AZD9056 formulation Phase III 200 mg (T); Drug: AZD9056 formulation Phase III 50 mg (T); Drug: AZD9056 formulation Phase IIb 50 mg (R)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00908934

EudraCT Number: 2009-010554-35

D1520C00004

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

1

Experimental group

Description:

50 or 400 mg AZD9056, Test formulation

Treatment:

Drug: AZD9056 formulation Phase III 50 mg (T)

Drug: AZD9056 formulation Phase III 200 mg (T)

2

Experimental group

Description:

50 or 400 mg AZD9056, Reference formulation

Treatment:

Drug: AZD9056 formulation Phase IIb 200mg (R)

Drug: AZD9056 formulation Phase IIb 50 mg (R)