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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00878618
First received: March 31, 2009
Last updated: June 2, 2009
Last verified: June 2009
  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 April 15, 2014