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Completed

NCT Number: NCT00878618

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD0837

Drug

Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2009
First posted
Apr 9, 2009
Registry last updated
Jun 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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