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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014