Radiprodil in Participants With Hepatic Impairment

Condition(s) studied

Investigational drug(s) / intervention(s)

Radiprodil: Radiprodil will be administered as a single oral dose of 15 mg (2.0 mL of 7.5 mg/mL oral suspension) on Day 1 under fed conditions. Participants will fast overnight for at least 10 hours prior to dosing and consume a standard breakfast approximately 30 minutes before administration. Study drug will be administered with approximately 240 mL of water. All participants across cohorts will receive the same single-dose regimen.

Study summary

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 adults aged 18 to 75 years will be enrolled into five cohorts based on liver function (mild, moderate, or severe hepatic impairment) or healthy status. Participants will receive a single 15 mg oral dose of radiprodil and remain in the clinical research unit for intensive PK and safety monitoring through Day 6.

The primary objective is to characterize the PK profile of radiprodil in participants with hepatic impairment compared with healthy participants. Safety and tolerability will also be assessed. Results from this study will help determine whether dose adjustments are needed in individuals with impaired liver function.

Eligibility

Primary outcome measure(s)

• Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Radiprodil — Day 1 (pre-dose) through Day 6 (120 hours post-dose)
  Plasma AUClast of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
• Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of Radiprodil — Day 1 (pre-dose) through Day 6 (120 hours post-dose)
  Plasma AUCinf of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
• Maximum Observed Plasma Concentration (Cmax) of Radiprodil — Day 1 (pre-dose) through Day 6 (120 hours post-dose)
  Plasma Cmax of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
• Time to Maximum Observed Plasma Concentration (Tmax) of Radiprodil — Day 1 (pre-dose) through Day 6 (120 hours post-dose)
  Plasma Tmax of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
• Time Before First Quantifiable Plasma Concentration (Tlag) of Radiprodil — Day 1 (pre-dose) through Day 6 (120 hours post-dose)
  Plasma Tlag of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
• Apparent Total Body Clearance (CL/F) of Radiprodil — Day 1 (pre-dose) through Day 6 (120 hours post-dose)
  Apparent total body clearance of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
• Apparent Volume of Distribution Based on the Terminal Phase (Vz/F) of Radiprodil — Day 1 (pre-dose) through Day 6 (120 hours post-dose)
  Apparent volume of distribution of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
• Terminal Elimination Half-Life (t½) of Radiprodil — Day 1 (pre-dose) through Day 6 (120 hours post-dose)
  Plasma terminal elimination half-life of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

Trial sites (2)

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