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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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05874336
Study type Interventional
Source Galmed Pharmaceuticals Ltd
Contact
Status Completed
Phase Phase 1
Start date June 17, 2020
Completion date August 11, 2020

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