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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD2624

Study type: Interventional

Funder types: Industry

Identifiers

NCT00867685

D0970C00008

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Treatment A

Experimental group

Description:

Single oral dose of 40 mg AZD2624 liquid suspension in a fasted state.

Treatment:

Drug: AZD2624

Drug: AZD2624

Treatment B

Experimental group

Description:

Single oral dose of 40 mg (2x20mg tablets)AZD2624 in a fasted state.

Treatment:

Drug: AZD2624

Drug: AZD2624

Treatment C

Experimental group

Description:

Single oral dose of 40 mg (2x20mg tablets) in a fed state.

Treatment:

Drug: AZD2624

Drug: AZD2624