Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets

Inclusion Criteria

• Male or female subjects
• Age between 18 and 45 years (inclusive of the date of signing the informed consent form)
• Male subjects must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and up to the study completion visit
• Female subjects who are not of reproductive potential. A female subject who is not of reproductive potential is defined as a subject who:

(i) has reached natural menopause (defined as at least 12 months of spontaneous amenorrhea); (ii) is at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (iii) has undergone bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying cause (e.g., anorexia nervosa).

• Female subjects who are of reproductive potential and use reliable contraception method and/or are willing to use adequate birth control methods starting from at least 4 weeks prior to the screening visit and for the duration of the study through 30 days after the last dose of study drug

List of medically accepted contraceptive methods:

• Combination of a barrier method and spermicides (film, jelly, foam): female/ male condoms with spermicides, as well as a diaphragm/ cervical cap/ contraceptive sponge with spermicides.
• Hormonal methods: combined estrogen/progestin injectable and oral contraceptives; progestin injectable and oral contraceptives; implants (Nexplanon®), vaginal ring (NuvaRing®), skin patch (Xulane®) and contraceptive injection (Depo-Provera®).
• Intrauterine devices (IUD): inert or copper IUD (ParaGard®), hormonal IUD (Mirena®, Skyla®, Kyleena®).
• Physically and mentally healthy as judged by means of medical and standard laboratory examinations
• Non-smokers or ex-smokers (stopped at least 12 months ago) and non-users of other nicotine containing products, confirmed by urine cotinine test
• Body mass index (BMI) within the range (including the borders) of 18.0 to 29.9 kg/m2
• Informed consent given in written form according to Section 5.3 of clinical study protocol

Exclusion Criteria

• Participation in another clinical study at the same time or within 90 days before the screening visit (calculated from the date of the final examination of the previous study)
• Randomization into the present study more than once
• Blood donation or blood loss including plasmapheresis of >500 mL within 90 days before screening visit
• History of drug abuse or use of illegal drugs: use of soft drugs, marihuana within 6 months before screening visit or hard drugs, cocaine, amphetamines, phencyclidine within 1 year before screening visit
• Alcohol abuse, regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits) or recovered alcoholics
• Regular consumption of beverages or food containing methylxanthines (coffee, tea, cola, caffeine containing sodas, chocolate) equivalent to more than 500 mg methylxanthines per day
• Positive drug screen
• Positive alcohol test
• Pregnant and/or nursing women. Positive pregnancy Human chorionic gonadotropin (hCG) test
• Allergic diathesis or any clinically significant allergic disease (asthma or bronchial hyperreactivity)
• Any history of drug hypersensitivity especially to the active and inactive ingredients of the Aramchol meglumine or Aramchol free acid preparations, including cholic acid
• Presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
• Clinically significant illness within 4 weeks before screening visit
• Major surgery of the gastrointestinal tract except for appendectomy
• Any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug
• History of difficulty in swallow