Radiprodil in Participants With Hepatic Impairment

Recruiting Phase 1 Interventional Study
Hepatic Impairment
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
40 (estimated)
Sponsor
GRIN Therapeutics, Inc. · Industry
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About This Trial
This Phase 1, open-label study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of radiprodil in adults with varying degrees of hepatic impairment compared with healthy participants. Radiprodil is being developed as a potential treatment for GRIN-related neurodevelopmental disorders, tuberous sclerosis complex, and focal cortical dysplasia. Approximately 40 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male or female participants aged 18 to 75 years, inclusive, at Screening. * Body mass index (BMI) within the range specified in the protocol. * Participants with hepatic impairment must have stable mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh…
Contacts

Laura Bardell

+1-877-225-0014

ClinicalTrials@GrinTherapeutics.com

CONTACT

Aneeta Saxena

CONTACT