Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered Under Fed Conditions in Healthy Chinese Volunteers

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-site, randomized, double-blind, double dummy, placebo-controlled single and multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of Aramchol in subjects of Chinese descent. Therefore, this study (Aramchol 015) has been undertaken to ascertain the PK profile of Aramchol following single and multiple doses in a Chinese population under fed conditions utilizing the light breakfast from Aramchol 004.

This study will consist of two parts and the subjects will be assigned to two parts.

In each part of the study, subjects will be enrolled in the study within 28 days of screening.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Galmed Pharmaceuticals Ltd
• Collaborators: Alpha IRB; Analyst Research Laboratories; Analyst Research Laboratories Ltd.; Diamond Pharma Services; Diamond Pharma Services Regulatory Affairs Consultancy; Kramer Consulting LLC; Kramer Consulting, LLC; WCCT Global

Criteria

Inclusion Criteria:

1. Healthy male and female subjects, born in China, both parents of Chinese descent, aged at screening between 18-50 years old (inclusive), and having not lived outside of China for more than 10 years (in total, confirmed by verbal report).

2. BMI ≥ 18.0 and ≤ 30.0.

3. Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and physical examination.

4. No significant abnormalities in ECG (eg, prolonged QTcF, prolonged PR interval) done at screening and on Days (0) before dosing session.

5. No clinically significant abnormalities in hematology, blood chemistry, or urinalysis lab tests at screening.

6. No known history of alcohol or drug abuse. Subjects with negative urinary drugs of abuse (DOA) screen determined on Day (0) before dosing session(s).

7. Negative human immunodeficiency virus (HIV), hepatitis B, and hepatitis C serology tests as evaluated at screening.

8. Negative urine pregnancy tests at screening and at check-in (women of childbearing potential only).

9. . Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.

10. All subjects must agree to use a highly effective method of birth control during the study and up to 15 days after the last study drug administration. A highly effective method of birth control is considered to be one of the following:

• An oral or implanted hormonal method of contraception (if it had been used for ≥3 months prior to study drug administration) while also using a barrier method (ie, condom or diaphragm)

• A hormone or copper intrauterine device if it had been in place for ≥3 months prior to study drug administration (subjects using nonhormonal or copper intrauterine devices were also required to use a barrier method of contraception)

• A vasectomized partner

• Total abstinence is acceptable; however, the subject is required to use a highly effective method of contraception if the subject decides subsequently not to abstain

• Periodic abstinence around ovulation is not considered acceptable

• Women who are either surgically sterilized or postmenopausal (last menstrual period at least 1 year prior to the screening visit) are exempt from this requirement. If medical records are not available to document sterility, urine pregnancy testing will be performed at screening and check-in.

11. Subjects must provide written informed consent to participate in the study.

Exclusion Criteria:

1. Documented history or on-going symptoms of any gastrointestinal disorder involving motility, gastric acid or gastric emptying or malabsorption, including but not limited to, peptic ulcer disease, gastroesophageal reflux, dyspepsia, gastroparesis, chronic diarrhea, chronic constipation, gall bladder disease, pancreatitis, lactose intolerance and celiac disease.

2. History of esophageal, gastric, biliary, or intestinal surgery (excluding herniotomy and appendectomy which are not related to gastrointestinal disorders).

3. Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.

4. Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at screening visit.

5. Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements within 14 days prior to dosing. Paracetamol or ibuprofen for symptomatic relief of pain is allowed until 24 hours prior to the study drug administration.

6. Subjects who have taken anticholinergic or other drugs known to affect gastrointestinal motility within 7 days prior to the first dosing.

7. Treatment with any drugs with known hepatic enzyme-inducing or inhibiting agents (eg, barbiturates, phenothiazines, cimetidine, carbamazepine) within 30 days prior to dosing.

8. Known clinically significant hypersensitivity and/or allergy to any drugs.

9. Subjects with recent significant change in body weight (±10% within 3 months of screening).

10. Any acute illness (eg, acute infection) within 48 hours prior to the first study drug administration, which is considered of significance by the Principal Investigator.

11. Participation in another clinical trial with drugs, received within 3 months prior to dosing (calculated from the previous study's last dosing date).

12. Female subjects who are pregnant or breastfeeding.

13. Subjects who donated blood in the three months or received blood or plasma derivatives in the six months preceding study drug administration.

14. Inability to fast or consume the food provided in the study (including any clinically significant known food allergies or food restrictions).

15. Subjects who are non-cooperative, unwilling or unable to communicate with the investigators and site staff (ie, language problem, poor mental development or impaired cerebral function).