Nocturia Clinical Trial
Official title:
Single Center, Open-Label, Single-Sequence, Within-Subject Study In Two Cohorts Of Healthy Male Subjects Comparing Single-Dose Pharmacokinetics Of Fedovapagon Alone And In Combination With A CYP3A4 Inhibitor, Itraconazole, Or A CYP3A4 Inducer, Rifampicin
The purpose of this study is to investigate the potential for co-administration of strong inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.
Fedovapagon is a vasopressin V2 receptor agonist in development for the treatment of
nocturia. Agonism of the V2 receptor, located in the collecting ducts of the kidney, leads
to translocation of aquaporin channels and increased re absorption of water and
anti-diuresis.
A number of drugs that are commonly co-prescribed in the population who may present for
treatment of nocturia are inhibitors of CYP3A4, including diltiazem, verapamil, erythromycin
and clarithromycin and may therefore impact the plasma levels of fedovapagon if co
administered.
Conversely, concomitant intake of drugs that are potent CYP3A4 inducers may lead to lower
than anticipated plasma concentrations of fedovapagon thus reducing the efficacy of
fedovapagon. It is therefore important to assess the effect of CYP3A4 induction on the
pharmacokinetic (PK) parameters of fedovapagon.
The study design uses itraconazole as a potent inhibitor of CYP3A4 and, in a separate cohort
of subjects, rifampicin as a potent CYP3A4 inducer at doses intended to maximize the
potential to demonstrate an interaction.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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