Comparison of Aramchol Concentrations With Once or Twice Daily Dosing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-08

Study Completion Date

2019-03-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol and Food Effect in Healthy Volunteers

NCT02374437

Healthy Volunteers

COMPLETED PHASE1

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

NCT07251712

Healthy

NOT_YET_RECRUITING PHASE1

Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment

NCT04480827

Hepatic Impairment

COMPLETED PHASE1

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

NCT02803996

Healthy Volunteers

COMPLETED PHASE1

An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability and Mass Balance of Aramchol

NCT05874336

NASH

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aramchol 300 mg

Aramchol 300 mg twice daily (every 12 hours)

Group Type EXPERIMENTAL

Aramchol

Intervention Type DRUG

One Aramchol tablet (300 mg) twice daily and 2 Aramchol tablets (300 mg each) once daily

Aramchol 600 mg

Aramchol 600 mg once daily (every 24 hours)

Group Type EXPERIMENTAL

Aramchol

Intervention Type DRUG

One Aramchol tablet (300 mg) twice daily and 2 Aramchol tablets (300 mg each) once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aramchol

One Aramchol tablet (300 mg) twice daily and 2 Aramchol tablets (300 mg each) once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female healthy volunteer.
2. Aged 18-45 years at time of consent.
3. A body mass index (BMI; Quetelet index) in the range 18.0-30.9.
4. Ability to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
5. Willingness to give written consent to participate after reading and understanding the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.
6. Agree to use effective contraception as described in Section 11.
7. Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.
8. Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).

Exclusion Criteria

1. Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception (see Section 11).
2. Of East Asian descent including, but not limited to, Chinese, Japanese, Korean, Mongolian, or Vietnamese.
3. Smoker, or has smoked cigarettes or other tobacco or nicotine products in the last 12 months.
4. Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (AP) \>ULN at the screening visit. A repeat is allowed on one occasion for determination of eligibility.
6. Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
7. History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs including gastrointestinal disorder or of oesophageal, gastric, biliary or intestinal surgery (excluding herniotomy and appendectomy).
8. Use of anticholinergic or other drugs known to affect gastrointestinal motility during the 7 days before the first dose of trial medication.
9. Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
10. Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.
11. Presence or history of severe adverse reaction to any drug or a history of sensitivity to aramchol, cholic acid, bile acid sequestrants, or any excipients in the tablets.
12. Use of a prescription medicine (except oral contraceptives in females), or any other medicine or herbal remedy (including St John's wort) known to interfere with enzymes in the liver, during the 28 days before the first dose of trial medication; or use of any other over-the-counter medicine, with the exception of acetaminophen (paracetamol), during the 7 days before the first dose of trial medication.
13. Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before first admission to this study; in the follow-up period of another clinical trial at the time of screening for this study.
14. Presence or history of drug or alcohol abuse, or intake of more than 14 units of alcohol weekly.
15. Blood pressure and heart rate in supine position at the screening examination outside the ranges: blood pressure 100-140 mm Hg systolic, 50-90 mm Hg diastolic; heart rate 45\_90 beats/min, unless judged not clinically significant. Borderline values (ie values that are within 5 mm Hg for blood pressure or 5 beats/min for heart rate) will be repeated. Subjects can be included if the repeat value is within range or still borderline, but deemed not clinically significant by the investigator.
16. Possibility that the volunteer will not cooperate with the requirements of the protocol.
17. Evidence of drug abuse on urine testing.
18. Positive test for hepatitis B, hepatitis C or HIV.
19. Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.
20. Objection by GP to volunteer entering trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes