Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD0837

Study type: Interventional

Funder types: Industry

Identifiers

NCT00878618

D1250C00056

Details and patient eligibility

About

The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subject aged between 18 to 45 years inclusive
• Body mass index (BMI) between 19 to 30 kg/m2 inclusive
• Body weight between 50 to 100 kg inclusive
• Women must be either post-menopausal, permanently sterilised or, if of childbearing potential, must have a negative pregnancy test before intake of study medication and use a reliable form of contraception before and during participation in the study.

Exclusion criteria

• Significant illness (including ongoing or history of liver disease), trauma or surgical procedures from 2 weeks before the pre-entry visit until the first administration of Investigational Product
• Clinical significant abnormalities in clinical chemistry, haematology or urinalysis result including positive result on screening tests for serum hepatitis B surface antigen, hepatitis C antibody or HIV or positive F-Hb result pre-entry
• History of bleeding disturbance (including extensive menstrual bleedings) or thrombotic disorder
• Clinically significant medical history, as judged by the investigator, including psychiatric disorders or severe allergies.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

HAB

Experimental group

Description:

AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast

Treatment:

Drug: AZD0837

HBA

Experimental group

Description:

AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast

Treatment:

Drug: AZD0837

LAB

Experimental group

Description:

AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast

Treatment:

Drug: AZD0837

LBA

Experimental group

Description:

AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast

Treatment:

Drug: AZD0837