NCT05874336

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Galmed Pharmaceuticals Ltd · Industry
• Sex: Male
• Age: 35 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• NASH

Interventions

Type	Name	Description
DRUG	Aramchol	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.

Timeline

• Start date: 2020-06-17
• Primary completion: 2020-08-11
• Completion: 2020-08-11
• First posted: 2023-05-24
• Last updated: 2023-05-24

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study