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Completed

NCT Number: NCT00867685

Phase I 2-Way Crossover Study to Assess Relative BA of Tablet Versus Liquid Suspension and Food Effect on Tablet Formulation

The purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet form of the same drug. This study will also study the effect of food on the tablet form of the drug.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female volunteers

Exclusion criteria

  • Donation of plasma or blood products within one month of of screening
  • Clinically relevant abnormalities in physical examination, vital signs,ECG, clinical chemistry, hematology, or urinalysis.
  • Previous participation in an AD2624 study.

Treatment and study plan

AZD2624

Drug

Single dose of 40 mg AZD2624 liquid suspension, PO

Primary outcomes

  1. Serial blood draws will be used to measure the plasma levels of AZD2624 for the liquid suspension and the tablet formulation in a fed and fasted state.

    Time frame: Seventeen blood draws will be collected during each treatment period for a total of 51 samples for the study.

Secondary outcomes

  1. Safety will be measured by the collection of AEs, ECGs, physical exams, and vital signs.

    Time frame: Subjects inquiry on AE daily, ECGs collected at 2 timepoints each period, clinical labs collected at 3 timepoints each period, physical exams completed 3 timepoints each period, and vital signs collected each day of each period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomized, Open Label, 2-Way Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of AZD2624 (Tablet Versus Liquid Suspension) Followed by an Additional Period to Assess the Food Effect on the Tablet

Important dates

Study start
2009
Study completion
2009
First posted
Mar 24, 2009
Registry last updated
Apr 30, 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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