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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD2624

• Registration Number: NCT00867685
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-18
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-24
• Status Verified: 2009-04
• Study Completion: 2009-04
• Last Update Submitted: 2009-04-29
• Last Update Posted: 2009-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	AZD2624	Single oral dose of 40 mg AZD2624 liquid suspension in a fasted state.
Treatment B	AZD2624	Single oral dose of 40 mg (2x20mg tablets)AZD2624 in a fasted state.
Treatment C	AZD2624	Single oral dose of 40 mg (2x20mg tablets) in a fed state.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States