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

Healthy Clinical Trial

Official title:

A Phase I, Single-Centre, Open, Randomized, Two-Way Crossover Study to Evaluate the Pharmacokinetics of the Extended-Release Test Formulation of AZD0837 Compared to the Extended-Release AZD0837 Reference Formulation After Repeated Dosing in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878618
• Other study ID #: D1250C00056
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2009
• Last updated: June 2, 2009
• Start date: April 2009
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD0837
Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days
• AZD0837
Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the pharmacokinetics of AZD0837 and the active metabolite AR-H067637XX for the extended-release test formulation of AZD0837 compared to the ER reference formulation.		Intense PK-sampling during 5 pre- defined study days for PK profiling. In 2 of the study days the subjects will have a breakfast before intake of the Investigational Product.	No
Secondary	To evaluate the PK of the intermediate metabolite AR-H069927XX		Since the metbolite will be evaluated from the AZD0837-samples the time frame is the same as above.	No
Secondary	Safety variables (ECG, pulse, blood pressure, safety lab, physical examination, adverse events)		ECG & physical examination at start and end of study. Pulse and blood pressure predose day 1 and every day 2 h post dose. Adverse events collected during the whole study. Safety lab at a few timepoints but APTT will be checked on 4 h post dose on day 1.	Yes
Secondary	Measurement of plasma concentrations of 4 beta-hydroxycholesterol to investigate whether AZD0837 affects the level of CYP3A4		Once predose on day 1, session 1 and once predose on day 5, session 2	No