NASHPhase 1NCT05874336
An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability and Mass Balance of Aramchol
A Phase 1 study testing Aramchol in people with NASH, run by Galmed Pharmaceuticals Ltd at 1 site in United Kingdom.
Trial summary
A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for [14C]-aramchol in healthy male subjects Read more about this study
- Who is it for?
- Ages 35 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- NASH
- What is being tested?
- Aramchol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jun 2020to 11 Aug 2020
- 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 35 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Aged 35 to 64 years at the time of signing informed consent
- Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening
- Must be willing and able to communicate and participate in the whole study
- Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
- Must provide written informed consent
- Must agree to adhere to the contraception requirements
Who cannot join
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- A confirmed positive alcohol breath test at screening or each admission
- Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or each admission
Show all 10Show fewer
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Subjects with pregnant or lactating partners
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
- Participation in any study involving administration of any [14C]-labelled compound within 12 months prior to dosing in Part 1 of this study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences, Mere Way, Ruddington Fields, Ruddington, Nottingham, NG11 6JS, UK.
Nottingham, NG11 6JS
About this study
Official title: An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability of Aramchol and to Determine the Mass Balance Recovery, Metabolite Profile and Metabolite Identification to Healthy Male Subjects
A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for [14C]-aramchol in healthy male subjects
Read the detailed description
A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for [14C]-aramchol in healthy male subjects.
A subject was considered evaluable in Part 1 if they provided PK samples for up to a minimum of 120 h after first investigational medicinal product (IMP) administration. A subject was considered evaluable in Part 2 if they provided biological samples for up to a minimum of 144 h after IMP administration or demonstrated >90% mass balance recovery, or <1% of the administered dose eliminated in excreta for 2 consecutive days, whichever was sooner.
- Conditions
- NASH
- Being tested
- Aramchol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AramcholDrug
Also called Aramchol free acid (3β-arachidylamido-7α,12α-dihydroxy-5β-cholan-24-oic acid)
Aramchol free acid (3β-arachidylamido-7α,12α-dihydroxy-5β-cholan-24-oic acid) is a synthetic small molecule, produced by conjugation of cholic acid (bile acid) and arachidic acid (saturated fatty acid) linked by a stable amide bond.
| Study group | Role | What they receive |
|---|---|---|
| Single dose administration of Aramchol in Part 1 and Part 2 | Experimental | 6 subjects received Aramchol in Part 1 and Part 2 of the study Receives: Drug: Aramchol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability
Measure the AUC(0-inf) of orally and intravenously (IV) administered Aramchol
Measured: 10 days
Mass balance recovery
Assess the mass balance recovery of total amounts of radioactivity excreted in urine and feces
Measured: 10 days
Metabolite profiling
Assess the potential metabolites of Aramchol and determine their chemical structure in plasma, urine and fecal samples
Measured: 10 days
Secondary outcomes (8)
Routes and rates of elimination
Determine the routes and rates of elimination of [14C]-Aramchol in excreta
Measured: 10 days
Chemical structure of each metabolite accounting for more than 10%
Identify the chemical structure of each metabolite accounting for more than 10% by area under the curve (AUC) of circulating total radioactivity or 10% of the dose in urine and feces
Measured: 10 days
PK- Area under the concentration-time curve (AUC)
Investigate the plasma Area under the concentration-time curve (AUC) of Aramchol
Measured: 10 days
PK- Time of maximum observed concentration (Tmax)
Investigate the plasma Time of maximum observed concentration (Tmax) of Aramchol
Measured: 10 days
PK- Maximum observed concentration (Cmax)
Investigate the plasma Maximum observed concentration (Cmax) of Aramchol
Measured: 10 days
PK- Total body clearance (CL)
Investigate the Total body clearance (CL) of Aramchol
Measured: 10 days
Safety- Adverse events
Assess and characterize the number of participants with adverse events
Measured: 10 days
Safety- Clinical laboratory parameters
Assess and characterize the number of participants with clinically significant changes in clinical laboratory parameters
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start17 Jun 2020
- Primary completion11 Aug 2020
- Study completion11 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galmed Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- John Posner, PhD, FRCP, Study director, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874336
- Sponsor's protocol ID
- Aramchol-020
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Consideration will be made whether to share any data of this mass balance study
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability of Aramchol and to Determine the Mass Balance Recovery, Metabolite Profile and Metabolite Identification to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05874336
- Acronym / sponsor ID
- Aramchol-020
- Conditions
- NASH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Galmed Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 24 May 2023 (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.
A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for [14C]-aramchol in healthy male subjects
Detailed description
A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for [14C]-aramchol in healthy male subjects.
A subject was considered evaluable in Part 1 if they provided PK samples for up to a minimum of 120 h after first investigational medicinal product (IMP) administration. A subject was considered evaluable in Part 2 if they provided biological samples for up to a minimum of 144 h after IMP administration or demonstrated >90% mass balance recovery, or <1% of the administered dose eliminated in excreta for 2 consecutive days, whichever was sooner.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose administration of Aramchol in Part 1 and Part 2 | Experimental | Drug: Aramchol6 subjects received Aramchol in Part 1 and Part 2 of the study |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males
- Aged 35 to 64 years at the time of signing informed consent
- Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening
- Must be willing and able to communicate and participate in the whole study
- Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
Key exclusion criteria (10 listed)
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- A confirmed positive alcohol breath test at screening or each admission
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 |
|---|---|---|
| AramcholAlso: Aramchol free acid (3β-arachidylamido-7α,12α-dihydroxy-5β-cholan-24-oic acid)Aramchol free acid (3β-arachidylamido-7α,12α-dihydroxy-5β-cholan-24-oic acid) is a synthetic small molecule, produced by conjugation of cholic acid (bile acid) and arachidic acid (saturated fatty acid) linked by a stable amide bond. | Drug | Single dose administration of Aramchol in Part 1 and Part 2 |
Primary outcome
Absolute bioavailability
Time frame: 10 days
Measure the AUC(0-inf) of orally and intravenously (IV) administered Aramchol
Mass balance recovery
Time frame: 10 days
Assess the mass balance recovery of total amounts of radioactivity excreted in urine and feces
Metabolite profiling
Time frame: 10 days
Assess the potential metabolites of Aramchol and determine their chemical structure in plasma, urine and fecal samples
8 secondary outcomes
Routes and rates of elimination
Time frame: 10 days
Chemical structure of each metabolite accounting for more than 10%
Time frame: 10 days
PK- Area under the concentration-time curve (AUC)
Time frame: 10 days
PK- Time of maximum observed concentration (Tmax)
Time frame: 10 days
PK- Maximum observed concentration (Cmax)
Time frame: 10 days
PK- Total body clearance (CL)
Time frame: 10 days
Safety- Adverse events
Time frame: 10 days
Safety- Clinical laboratory parameters
Time frame: 10 days
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 24 May 2023.
- Individual participant dataSharing planned: No. Consideration will be made whether to share any data of this mass balance study
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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.
John Posner, PhD, FRCP study director
Consultant
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 NASH, 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 7 inclusion and 10 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 24 May 2023. 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?
Absolute bioavailability (time frame: 10 days). The study lists 3 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 24 May 2023.