Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults

GRIN Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Tuberous Sclerosis Complex (TSC); Focal Cortical Dysplasia; Other Neurological Disorders

Treatments: Drug: Radiprodil with Carbamazepine; Drug: Radiprodil with Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06965881

RAD-GRIN-504

Details and patient eligibility

About

This is a Phase 1, open-label, 2-part study to evaluate the effect of multiple doses of oral carbamazepine or oral itraconazole on the plasma pharmacokinetic profile of radiprodil in healthy adult participants. In addition, the safety and tolerability of radiprodil given together with oral carbamazepine or itraconazole will be assessed.

Full description

This is an open label study conducted in healthy adult volunteers. The study will be conducted in 2 parallel parts. A total of 36 participants will be enrolled in the study (N=18 per Part).

Part A: will enrol 18 participants to receive multiple oral doses of the radiprodil in the range of 7.5mg to 30mg with oral carbamazepine.

Part B: will enrol 18 participants to receive multiple oral doses of radiprodil in the range of 7.5mg to 15mg with oral itraconazole.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female adults between 18 and 55 years of age, inclusive, at Screening
• Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weighs at least 50 kg at Screening
• Medically healthy in the opinion of the PI or delegate
• Female participants must be non-lactating and of non-child-bearing potential; or if child-bearing potential must agree to not to attempt to become pregnant or donate ova from signing consent until at least 90 days after the last dose of study drug and must agree to use adequate contraception
• Male participants must agree to not donate sperm from signing consent until at least 90 days after the last dose of study drug and must agree to use adequate contraception
• Have suitable venous access for blood sampling.
• Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions

Exclusion criteria

• Known hypersensitivity to the study drug or any of the study drug ingredients
• Genetic testing positive for HLA genotypes
• Has a history of severe allergic or anaphylactic reaction
• Has history of surgery in the past 90 days prior to Day 1
• Has a history of of risk factors for torsade de pointes or a known arrythmia
• Has a history of or positive serology for HIV, Hepatitis B or Hepatitis C virus at Screening.
• Has a history of suicide attempts or deliberate self-harm
• Use of cannabidiol (CBD) within 30days of Day -1
• Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day
• Routine consumption of an average of more than five (5) 240 mL servings of coffee or other caffeinated beverages per day
• Use of tobacco-containing products and nicotine or nicotine containing products in the 2 months prior to Day -1
• Women of childbearing potential using oral, injected or implanted hormonal contraception
• Has any other condition or prior therapy that, in the opinion of the Investigator or delegate, may potentially compromise the safety or compliance of the participant, or may preclude the participant from successfully completing the study.

Other inclusion/exclusion eligibility criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Part A: Radiprodil with Carbamazepine

Experimental group

Description:

Participants will receive multiple oral doses of Radiprodil with Carbamazepine to evaluate the effect that carbamazepine may have on Radiprodil.

Treatment:

Drug: Radiprodil with Carbamazepine

Part B: Radiprodil with Itraconazole

Experimental group

Description:

Participants will receive multiple oral doses of Radiprodil with Itraconazole to evaluate the effect that itraconazole may have on Radiprodil.

Treatment:

Drug: Radiprodil with Itraconazole