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

NASH Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05874336
• Other study ID #: Aramchol-020
• Status: Completed
• Phase: Phase 1
• Start date: June 17, 2020
• Est. completion date: August 11, 2020

Study information

• Verified date: April 2023
• Source: Galmed Pharmaceuticals Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 11, 2020
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• NASH

Intervention

Drug:
• Aramchol
Aramchol free acid (3ß-arachidylamido-7a,12a-dihydroxy-5ß-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.

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences, Mere Way, Ruddington Fields, Ruddington, Nottingham, NG11 6JS, UK.	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Galmed Pharmaceuticals Ltd	Quotient Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute bioavailability	Measure the AUC(0-inf) of orally and intravenously (IV) administered Aramchol	10 days
Primary	Mass balance recovery	Assess the mass balance recovery of total amounts of radioactivity excreted in urine and feces	10 days
Primary	Metabolite profiling	Assess the potential metabolites of Aramchol and determine their chemical structure in plasma, urine and fecal samples	10 days
Secondary	Routes and rates of elimination	Determine the routes and rates of elimination of [14C]-Aramchol in excreta	10 days
Secondary	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	10 days
Secondary	PK- Area under the concentration-time curve (AUC)	Investigate the plasma Area under the concentration-time curve (AUC) of Aramchol	10 days
Secondary	PK- Time of maximum observed concentration (Tmax)	Investigate the plasma Time of maximum observed concentration (Tmax) of Aramchol	10 days
Secondary	PK- Maximum observed concentration (Cmax)	Investigate the plasma Maximum observed concentration (Cmax) of Aramchol	10 days
Secondary	PK- Total body clearance (CL)	Investigate the Total body clearance (CL) of Aramchol	10 days
Secondary	Safety- Adverse events	Assess and characterize the number of participants with adverse events	10 days
Secondary	Safety- Clinical laboratory parameters	Assess and characterize the number of participants with clinically significant changes in clinical laboratory parameters	10 days