Clinical Trials in the USA / NCT07884734
Active, not recruiting
Phase 1
A Study to Evaluate the Effect of Carbamazepine or Itraconazole on Radiprodil in Healthy Adult Participants
NCT07884734 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Adult Participants
Investigational drug(s) / intervention(s)
Radiprodil: Radiprodil administered orally as a single dose of 30 mg in Part A or 15 mg in Part B under fed conditions.
Carbamazepine: Carbamazepine administered orally twice daily at doses of 100 mg, 200 mg, and 300 mg in Part A to evaluate the effect of CYP3A4 induction on the pharmacokinetics of radiprodil.
Itraconazole (200 mg): Itraconazole administered orally at 200 mg once daily in Part B to evaluate the effect of CYP3A4 inhibition on the pharmacokinetics of radiprodil.
Study summary
This is a Phase 1, open-label, 2-part study in healthy adult participants to evaluate the pharmacokinetics and safety of radiprodil when coadministered with either the CYP3A4 inducer carbamazepine or the CYP3A4 inhibitor itraconazole. Up to 36 participants will be enrolled, with approximately 18 participants in Part A and 18 participants in Part B.
Eligibility
Inclusion Criteria:
* Healthy male and female adults aged 18 to 55 years inclusive at Screening.
* Body mass index between 18 and 32 kg/m² inclusive and weight of at least 50 kg at Screening.
* Healthy in the opinion of the Principal Investigator, based on medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory assessments.
* Female participants must be non-lactating and either of non-childbearing potential, postmenopausal, or, if of childbearing potential, must have negative pregnancy tests and agree to required contraception and ova donation restrictions.
* Male participants must agree to sperm donation restrictions and required contraception measures.
* For Part A only, participants must not be of Asian descent due to increased risk associated with carbamazepine exposure.
* Able to provide signed informed consent and comply with study requirements, including dietary restrictions and confinement at the clinical research unit.
Exclusion Criteria:
* History of contraindication or hypersensitivity to radiprodil, carbamazepine, itraconazole, or formulation components.
* For Part A only, HLA genotypes associated with increased risk of carbamazepine-induced severe cutaneous adverse reactions.
* Any medical condition that, in the opinion of the Principal Investigator, would pose additional risk or interfere with drug absorption, distribution, metabolism, or excretion.
* Pregnancy, breastfeeding, or positive pregnancy test.
* Significant neuropsychiatric, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, urologic, neurological, malignancy, psychiatric disease, brain surgery, or brain injury.
* Clinically significant allergic conditions.
* History of illicit drug abuse or alcohol abuse within 2 years of Screening.
* History of suicide attempt, deliberate self-harm, significant suicidal ideation, or suicidal behaviour on C-SSRS.
* Excessive alcohol or caffeine consumption.
* Positive drug, alcohol, cotinine, or relevant substance screen at Screening or Day -1.
* Recent marijuana, tobacco, nicotine, prescription drug, investigational product, OTC medication, herbal product, vaccine, blood donation, acute illness, relevant surgery, or blood transfusion as defined in the protocol.
* Positive serology for HBsAg, HCV antibody, or HIV antibody.
* Abnormal blood pressure, pulse rate, clinically significant ECG abnormality, QTcF \>450 msec, or history of prolonged QT syndrome.
* Restricted food or drink consumption before dosing, including alcohol, grapefruit/pomelo/star fruit/Seville orange products, poppy seeds, and xanthine-containing products.
* Poor venous access.
* Women of childbearing potential using oral, injected, or implanted hormonal contraception.
Primary outcome measure(s)
- AUClast of Radiprodil - Part A — Part A: Day 1 through Day 19
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUClast) of radiprodil following administration of radiprodil alone on Day 1 and with carbamazepine on Day 16. The effect of carbamazepine will be assessed using the geometric mean ratio and 90% confidence interval. - AUCinf of Radiprodil - Part A — Part A: Day 1 through Day 19
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf) of radiprodil following administration of radiprodil alone on Day 1 and with carbamazepine on Day 16. The effect of carbamazepine will be assessed using the geometric mean ratio and 90% confidence interval. - Cmax of Radiprodil - Part A — Part A: Day 1 through Day 19
Maximum observed plasma concentration (Cmax) of radiprodil following administration of radiprodil alone on Day 1 and with carbamazepine on Day 16. The effect of carbamazepine will be assessed using the geometric mean ratio and 90% confidence interval. - AUClast of Radiprodil - Part B — Part B: Day 1 through Day 12
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUClast) of radiprodil following administration of radiprodil alone on Day 1 and with itraconazole on Day 9. The effect of itraconazole will be assessed using the geometric mean ratio and 90% confidence interval. - AUCinf of Radiprodil - Part B — Part B: Day 1 through Day 12
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf) of radiprodil following administration of radiprodil alone on Day 1 and with itraconazole on Day 9. The effect of itraconazole will be assessed using the geometric mean ratio and 90% confidence interval. - Cmax of Radiprodil - Part B — Part B: Day 1 through Day 12
Maximum observed plasma concentration (Cmax) of radiprodil following administration of radiprodil alone on Day 1 and with itraconazole on Day 9. The effect of itraconazole will be assessed using the geometric mean ratio and 90% confidence interval.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| California Clinical Trials Medical Group (CCTMG) | Glendale | California |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07884734 on ClinicalTrials.gov ↗ ← All trials in the USA