Healthy
Conditions
Keywords
Healthy volunteers
Brief 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.
Interventions
DRUGAZD0837
Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
| 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. |
| 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 |
Countries
Sweden
Outcome results
None listed