AZD9056 Relative Bioavailability Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00908934

Enrollment

Registered

2009-05-27

Start date

2009-05-31

Completion date

2009-07-31

Last updated

2009-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Relative Bioavailability, AZD9056

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.

Interventions

DRUGAZD9056 formulation Phase III 50 mg (T)

Given as 50 mg tablet (T)

DRUGAZD9056 formulation Phase IIb 50 mg (R)

Given as 50 mg tablet (R)

DRUGAZD9056 formulation Phase III 200 mg (T)

Given as 400 mg (2 x 200 mg tablet (T))

DRUGAZD9056 formulation Phase IIb 200mg (R)

Given as 400 mg (2 x 200 mg tablet (R))

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026