Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: AZD0837	Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the PK of the intermediate metabolite AR-H069927XX [ Time Frame: Since the metbolite will be evaluated from the AZD0837-samples the time frame is the same as above. ] [ Designated as safety issue: No ]
Safety variables (ECG, pulse, blood pressure, safety lab, physical examination, adverse events) [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
Measurement of plasma concentrations of 4 beta-hydroxycholesterol to investigate whether AZD0837 affects the level of CYP3A4 [ Time Frame: Once predose on day 1, session 1 and once predose on day 5, session 2 ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	April 2009
Study Completion Date:	May 2009

Arms	Assigned Interventions
Experimental: HAB AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast	Drug: AZD0837 Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days
Experimental: HBA AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast	Drug: AZD0837 Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days
Experimental: LAB AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast	Drug: AZD0837 Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days
Experimental: LBA AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast	Drug: AZD0837 Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878618

Locations

Sweden
Research Site
Uppsala, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Elisabeth Edén Eden

Quintiles AB, Uppsala, Sweden

More Information

No publications provided

Responsible Party:	Karin Wåhlander, Medical Science Director, AstraZeneca R&D Mölndal
ClinicalTrials.gov Identifier:	NCT00878618 History of Changes
Other Study ID Numbers:	D1250C00056
Study First Received:	March 31, 2009
Last Updated:	June 2, 2009
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Healthy volunteers

ClinicalTrials.gov processed this record on June 17, 2013