The trial is an open-label, 2-period, randomised, crossover study of the plasma concentrations of aramchol, in which subjects will receive oral doses of aramchol at 300 mg twice daily and 600 mg once daily.
The trial is an open-label, 2-period, randomised, crossover study of the plasma concentrations of aramchol, in which subjects will receive oral doses of aramchol at 300 mg twice daily (every 12 h) for 9 days in one period, with a single dose in the morning of Day 10, and 600 mg once daily (every 24 h) for 10 days in the other period. A pharmacokinetic profile will be obtained over the dosing interval on Day 10 of each period. Enrolment of 16 subjects is planned with each subject taking part in the 2 study periods. The subjects will be randomised 1:1 so that 8 subjects receive each regimen in the first period and the alternate regimen in the second period. Subjects will be screened within 21 days before their first dose of study medicine. In each period they will remain resident on the ward from Day -1 until the morning of Day 11. Subjects will attend a follow-up visit 14 days (±2 days) after the end of the second period. There will be an interval of at least 7 days between Periods 1 and 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
One Aramchol tablet (300 mg) twice daily and 2 Aramchol tablets (300 mg each) once daily
Hammersmith Medicines Research (HMR)
London, United Kingdom
Pharmacokinetics (PK) of aramchol
AUC
Time frame: PK parameters will be measured on Days 7, 8 , 9, and 10.
Pharmacokinetics of aramchol
Cavg
Time frame: PK parameters will be measured on Days 7, 8 , 9, and 10.
PK of aramchol
Ctau
Time frame: PK parameters will be measured on Days 7, 8 , 9, and 10.
Pharmacokinetics (PK) of aramchol
Tmax
Time frame: K parameters will be measured on Days 7, 8 , 9, and 10.
Vital signs and physical examination
Systolic and diastolic blood pressure, Heart rate, Oral temperature and Respiratory rate
Time frame: During both treatment periods vital signs will be assessed on Days 1, 5 and 10.
Electrocardiogram
12-lead ECGs
Time frame: During both treatment periods ECG will be assessed on Days 1, 5 and 10.
Laboratory safety tests: Biochemistry
Usual tests.
Time frame: On Day -1, Day 5,on Day 11.
Laboratory safety tests: Hematology
haemoglobin, red blood cells, mean corpuscular volume , mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, haematocrit, white blood cells and platelets.
Time frame: On Day -1, Day 5,on Day 11.
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Laboratory safety tests: Urinalysis
Usual Dipstick test
Time frame: On Day -1, Day 5,on Day 11.
Safety and tolerability: Adverse events (AEs).
Adverse events are collected during entire study period.
Time frame: From screening visit to 14 days after the last dose in period 2.