Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From an Aramchol Meglumine Tablet

A Phase I Open-label Trial in Healthy Volunteers to Evaluate the Exposure of Aramchol From Two Different Single Doses of an Aramchol Meglumine Tablet

Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine tablet.

Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine given one daily with that from a 300 mg dose of Aramchol free acid tablets given twice daily in adult Healthy volunteers.

Inclusion Criteria:

• Male or female healthy volunteers with body mass index (BMI) in the range of 18-30.9 kg/ m2 inclusive
• Deemed healthy on the basis of clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
• Agree to follow-up the contraception requirements of the trial
• Able to give fully informed written consent

Exclusion Criteria:

• Females of reproductive potential who are pregnant or lactating
• Positive tests for hepatitis B, C or HIV
• History of sever adverse reaction to any drug
• Known sensitivity to drug medication
• Drug or alcohol abuse
• Smoking in the 3 months prior the study
• Clinically relevant abnormal lab results, medical history or concurrent medical condition
• Evidence of acute or chronic disease
• Inability to adhere to study requirements