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

AstraZeneca16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AZD2624DRUG

Single dose of 40 mg AZD2624 liquid suspension, PO

AZD2624DRUG

Single dose of 40 mg AZD 2624 (2x20mg tablets), PO

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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