HealthyPhase 1NCT03774173
Comparison of Aramchol Concentrations With Once or Twice Daily Dosing
A Phase 1 study testing Aramchol in people with Healthy, run by Galmed Pharmaceuticals Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aramchol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2018to 5 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 20Show fewer
- 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.
- Possibility that the volunteer will not cooperate with the requirements of the protocol.
- Evidence of drug abuse on urine testing.
- Positive test for hepatitis B, hepatitis C or HIV.
- Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.
- Objection by GP to volunteer entering trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research (HMR)
London, NW10 7EW
About this study
Official title: A Randomised, Open-label Study to Compare Plasma Concentrations of Aramchol in Healthy Volunteers After Once or Twice Daily Oral Dosing to Steady State
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.
Read the detailed description
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
- Healthy
- Being tested
- Aramchol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AramcholDrug
One Aramchol tablet (300 mg) twice daily and 2 Aramchol tablets (300 mg each) once daily
| Study group | Role | What they receive |
|---|---|---|
| Aramchol 300 mg | Experimental | Aramchol 300 mg twice daily (every 12 hours) Receives: Drug: Aramchol |
| Aramchol 600 mg | Experimental | Aramchol 600 mg once daily (every 24 hours) Receives: Drug: Aramchol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of aramchol
AUC
Measured: PK parameters will be measured on Days 7, 8 , 9, and 10.
Pharmacokinetics of aramchol
Cavg
Measured: PK parameters will be measured on Days 7, 8 , 9, and 10.
PK of aramchol
Ctau
Measured: PK parameters will be measured on Days 7, 8 , 9, and 10.
Pharmacokinetics (PK) of aramchol
Tmax
Measured: K parameters will be measured on Days 7, 8 , 9, and 10.
Secondary outcomes (6)
Vital signs and physical examination
Systolic and diastolic blood pressure, Heart rate, Oral temperature and Respiratory rate
Measured: During both treatment periods vital signs will be assessed on Days 1, 5 and 10.
Electrocardiogram
12-lead ECGs
Measured: During both treatment periods ECG will be assessed on Days 1, 5 and 10.
Laboratory safety tests: Biochemistry
Usual tests.
Measured: On Day -1, Day 5,on Day 11.
Laboratory safety tests: Hematology
haemoglobin, red blood cells, mean corpuscular volume , mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, haematocrit, white blood cells and platelets.
Measured: On Day -1, Day 5,on Day 11.
Laboratory safety tests: Urinalysis
Usual Dipstick test
Measured: On Day -1, Day 5,on Day 11.
Safety and tolerability: Adverse events (AEs).
Adverse events are collected during entire study period.
Measured: From screening visit to 14 days after the last dose in period 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start8 Dec 2018
- Primary completion3 Feb 2019
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galmed Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research, Analyst Research Laboratories, Diamond Pharma Services Regulatory Affairs Consultancy
- Responsible party
- Sponsor
- Investigators
- Adeep Puri, M.D., Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774173
- Sponsor's protocol ID
- Aramchol 017
- Status last verified
- Aug 2019
- First submitted
- 29 Nov 2018
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label Study to Compare Plasma Concentrations of Aramchol in Healthy Volunteers After Once or Twice Daily Oral Dosing to Steady State
- ClinicalTrials.gov ID
- NCT03774173
- Acronym / sponsor ID
- Aramchol 017
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Galmed Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research, Analyst Research Laboratories, Diamond Pharma Services Regulatory Affairs Consultancy
- Study start
- 8 Dec 2018 (actual)
- Primary completion
- 3 Feb 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aramchol 300 mg | Experimental | Drug: AramcholAramchol 300 mg twice daily (every 12 hours) |
| Aramchol 600 mg | Experimental | Drug: AramcholAramchol 600 mg once daily (every 24 hours) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AramcholOne Aramchol tablet (300 mg) twice daily and 2 Aramchol tablets (300 mg each) once daily | Drug | Aramchol 300 mg, Aramchol 600 mg |
Primary outcome
Pharmacokinetics (PK) of aramchol
Time frame: PK parameters will be measured on Days 7, 8 , 9, and 10.
AUC
Pharmacokinetics of aramchol
Time frame: PK parameters will be measured on Days 7, 8 , 9, and 10.
Cavg
PK of aramchol
Time frame: PK parameters will be measured on Days 7, 8 , 9, and 10.
Ctau
Pharmacokinetics (PK) of aramchol
Time frame: K parameters will be measured on Days 7, 8 , 9, and 10.
Tmax
6 secondary outcomes
Vital signs and physical examination
Time frame: During both treatment periods vital signs will be assessed on Days 1, 5 and 10.
Electrocardiogram
Time frame: During both treatment periods ECG will be assessed on Days 1, 5 and 10.
Laboratory safety tests: Biochemistry
Time frame: On Day -1, Day 5,on Day 11.
Laboratory safety tests: Hematology
Time frame: On Day -1, Day 5,on Day 11.
Laboratory safety tests: Urinalysis
Time frame: On Day -1, Day 5,on Day 11.
Safety and tolerability: Adverse events (AEs).
Time frame: From screening visit to 14 days after the last dose in period 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeep Puri, M.D. principal investigator
Hammersmith Medicines Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aramchol in people with Healthy, run by Galmed Pharmaceuticals Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) of aramchol (time frame: PK parameters will be measured on Days 7, 8 , 9, and 10.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.