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

NCT05874336 | Completed Phase 1 FDA Drug

• 1 other identifier: Aramchol-020
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

NASH

Outcome Measures

Primary Outcomes (3)

• Absolute bioavailability

  Measure the AUC(0-inf) of orally and intravenously (IV) administered Aramchol

  10 days

• Mass balance recovery

  Assess the mass balance recovery of total amounts of radioactivity excreted in urine and feces

  10 days

• Metabolite profiling

  Assess the potential metabolites of Aramchol and determine their chemical structure in plasma, urine and fecal samples

  10 days

Secondary Outcomes (8)

• Routes and rates of elimination

  10 days

• Chemical structure of each metabolite accounting for more than 10%

  10 days

• PK- Area under the concentration-time curve (AUC)

  10 days

• PK- Time of maximum observed concentration (Tmax)

  10 days

• PK- Maximum observed concentration (Cmax)

  10 days

Study Arms (1)

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

Drug: Aramchol

Interventions

Aramchol DRUG

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.

Also known as: Aramchol free acid (3β-arachidylamido-7α,12α-dihydroxy-5β-cholan-24-oic acid)

Single dose administration of Aramchol in Part 1 and Part 2

Eligibility Criteria

• Age: 35 Years - 64 Years
• Gender Eligibility Details: Healthy male subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Galmed Pharmaceuticals Ltd: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences, Mere Way, Ruddington Fields, Ruddington, Nottingham, NG11 6JS, UK.

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

aramchol

Study Officials

• John Posner, PhD, FRCP

  Consultant

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 24, 2023
• Study Start: June 17, 2020
• Primary Completion: August 11, 2020
• Study Completion: August 11, 2020
• Last Updated: May 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)