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.
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
Aneeta Saxena
CONTACT