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Completed

NCT Number: NCT00908934

AZD9056 Relative Bioavailability Study

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD9056 formulation Phase III 50 mg (T)

Drug

Given as 50 mg tablet (T)

AZD9056 formulation Phase IIb 50 mg (R)

Drug

Given as 50 mg tablet (R)

AZD9056 formulation Phase III 200 mg (T)

Drug

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

AZD9056 formulation Phase IIb 200mg (R)

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)

    Time frame: Frequent sampling occasions throughout the study period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2009
First posted
May 27, 2009
Registry last updated
Jul 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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