Comparison of Aramchol Concentrations With Once or Twice Daily Dosing

NCT03774173 | Completed Phase 1

• 1 other identifier: Aramchol 017
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics (PK) of aramchol

  AUC

  PK parameters will be measured on Days 7, 8 , 9, and 10.

• Pharmacokinetics of aramchol

  Cavg

  PK parameters will be measured on Days 7, 8 , 9, and 10.

• PK of aramchol

  Ctau

  PK parameters will be measured on Days 7, 8 , 9, and 10.

• Pharmacokinetics (PK) of aramchol

  Tmax

  K parameters will be measured on Days 7, 8 , 9, and 10.

Secondary Outcomes (6)

• Vital signs and physical examination

  During both treatment periods vital signs will be assessed on Days 1, 5 and 10.

• Electrocardiogram

  During both treatment periods ECG will be assessed on Days 1, 5 and 10.

• Laboratory safety tests: Biochemistry

  On Day -1, Day 5,on Day 11.

• Laboratory safety tests: Hematology

  On Day -1, Day 5,on Day 11.

• Laboratory safety tests: Urinalysis

  On Day -1, Day 5,on Day 11.

Study Arms (2)

Aramchol 300 mg

EXPERIMENTAL

Aramchol 300 mg twice daily (every 12 hours)

Drug: Aramchol

Aramchol 600 mg

EXPERIMENTAL

Aramchol 600 mg once daily (every 24 hours)

Drug: Aramchol

Interventions

Aramchol DRUG

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

Aramchol 300 mg; Aramchol 600 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female healthy volunteer.
• Aged 18-45 years at time of consent.
• A body mass index (BMI; Quetelet index) in the range 18.0-30.9.
• 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.
• 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.
• Agree to use effective contraception as described in Section 11.
• Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.
• Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).

You may not qualify if:

• 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).
• Of East Asian descent including, but not limited to, Chinese, Japanese, Korean, Mongolian, or Vietnamese.
• Smoker, or has smoked cigarettes or other tobacco or nicotine products in the last 12 months.
• 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.
• 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.
• 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.
• 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).
• Use of anticholinergic or other drugs known to affect gastrointestinal motility during the 7 days before the first dose of trial medication.
• Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
• Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.
• 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.
• 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.
• 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.
• Presence or history of drug or alcohol abuse, or intake of more than 14 units of alcohol weekly.
• 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.

Sponsors & Collaborators

• Galmed Pharmaceuticals Ltd: lead
• Hammersmith Medicines Research: collaborator
• Analyst Research Laboratories: collaborator
• Diamond Pharma Services Regulatory Affairs Consultancy: collaborator

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Interventions

aramchol

Study Officials

• Adeep Puri, M.D.

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 12, 2018
• Study Start: December 8, 2018
• Primary Completion: February 3, 2019
• Study Completion: March 5, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)