Clinical trial NCT05874336: An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability and Mass Balance of Aramchol
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NASH
Lead sponsor: Galmed Pharmaceuticals Ltd
Sponsor class: INDUSTRY
Collaborators: name: Quotient Sciences
First posted: 2023-05-24
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Healthy males
2. Aged 35 to 64 years at the time of signing informed consent
3. Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening
4. Must be willing and able to communicate and participate in the whole study
5. Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
6. Must provide written informed consent
7. Must agree to adhere to the contraception requirements

Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
3. History of any drug or alcohol abuse in the past 2 years
4. 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)
5. A confirmed positive alcohol breath test at screening or each admission
6. 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
7. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
8. Subjects with pregnant or lactating partners
9. 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
10. Participation in any study involving administration of any \[14C\]-labelled compound within 12 months prior to dosing in Part 1 of this study

Primary outcomes:
measure: Absolute bioavailability
timeFrame: 10 days
measure: Mass balance recovery
timeFrame: 10 days
measure: Metabolite profiling
timeFrame: 10 days
Secondary outcomes:
measure: Routes and rates of elimination
timeFrame: 10 days
measure: Chemical structure of each metabolite accounting for more than 10%
timeFrame: 10 days
measure: PK- Area under the concentration-time curve (AUC)
timeFrame: 10 days
measure: PK- Time of maximum observed concentration (Tmax)
timeFrame: 10 days
measure: PK- Maximum observed concentration (Cmax)
timeFrame: 10 days
measure: PK- Total body clearance (CL)
timeFrame: 10 days
measure: Safety- Adverse events
timeFrame: 10 days
measure: Safety- Clinical laboratory parameters
timeFrame: 10 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences, Mere Way, Ruddington Fields, Ruddington, Nottingham, NG11 6JS, UK.
Study officials:
affiliation: Consultant
name: John Posner, PhD, FRCP
role: STUDY_DIRECTOR
References: