Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Olinciguat ([14C]-IW-1701) Following a Single Oral Dose in Healthy Male Subjects
The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of [14C]-olinciguat.
OLI-103 is a Phase 1 open-label, nonrandomized, single-dose study in up to 8 subjects that
will be conducted at a single center in the US. Safety assessments will be performed
throughout the clinic period and multiple PK samples will be collected. Subjects will be
confined to the clinical research center for at least 8 days.
The purpose of the study is to determine the absorption, metabolism, and excretion of
[14C]-olinciguat and to characterize and determine, where possible, the metabolites present
in plasma, urine, and feces after a single oral dose. The study will help identify and
characterize olinciguat metabolites, evaluate the likelihood of effects of liver or kidney
impairment on the disposition of olinciguat, and assess the likelihood of drug-drug
interactions with olinciguat.
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