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Study was terminated due to the lack of operational capabilities of the sites to segregate participants as needed.
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| Name | Class |
|---|---|
| Avance Clinical Pty Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Radiprodil with Carbamazepine | Experimental | Participants will receive multiple oral doses of Radiprodil with Carbamazepine to evaluate the effect that carbamazepine may have on Radiprodil. |
|
| Part B: Radiprodil with Itraconazole | Experimental | Participants will receive multiple oral doses of Radiprodil with Itraconazole to evaluate the effect that itraconazole may have on Radiprodil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiprodil with Carbamazepine | Drug | Participants will receive oral doses of Radiprodil in the range of 7.5mg to 30mg along with oral doses of Carbamazepine in the range of 100mg to 300mg twice daily over a period of 27 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: To assess the effect of oral carbamazepine on the maximum observed plasma concentration (Cmax) of oral dosing of radiprodil | Blood samples will be collected on Days 7 to 10 and 25 to 28. | |
| Part B: To assess the effect of oral itraconazole on the maximum plasma concentration (Cmax) of oral dosing of radiprodil | Blood samples will be collected Days 5 to 9 and 18 to 22. | |
| Part A: To asses the effect of oral carbamazepine on radiprodil area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) | Blood samples will be collected on Days 7 to 10 and 25 to 28. | |
| Part B: To asses the effect of oral itraconazole on the radiprodil area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) | Blood samples will be collected Days 5 to 9 and 18 to 22. | |
| Part A: To assess the effect of oral oral carbamazepine on the area under the plasma concentration-time curve to the end of dosing interval (AUCtau) of oral dosing of radiprodil | Blood samples will be collected on Days 7 to 10 and 25 to 28 | |
| Part B: To assess the effect of oral itraconazole on the area under the plasma concentration-time curve to the end of dosing interval (AUCtau) of oral dosing of radiprodil | Blood samples will be collected Days 5 to 9 and 18 to 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), TEAEs Leading to Discontinuation and Severity of TEAEs | Frequency, type, severity and duration of adverse events, serious adverse events and adverse drug reactions. | From Screening to Day 30 and follow up visit 30 days post last dose |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion eligibility criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Russell Chin | GRIN Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm Pty Ltd | Brisbane | Queensland | 4006 | Australia | ||
| Nucleus Network Pty Ltd |
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| Radiprodil with Itraconazole | Drug | Participants will receive oral doses of Radiprodil in the range of 7.5mg to 15mg along with oral doses of Itraconazole 200mg twice daily over a period of 21 days. |
|
| Part A: To assess the area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) of carbamazepine and carbamazepine metabolites following oral dosing of carbamazepine alone and in the presence of radiprodil |
| Blood samples for plasma PK will be collected on Days 18 and 25. |
| Part B: To assess the area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) of itraconazole following oral dosing of itraconazole alone and in the presence of radiprodil | Blood samples for plasma PK will be collected on Days 13 and 18. |
| Part B: To assess the area under the plasma concentration-time curve to the end of dosing interval (AUCtau) of itraconazole following oral dosing of itraconazole alone and in the presence of radiprodil | Blood samples for plasma PK will be collected on Days 13 and 18. |
| Part A: To assess the area under the plasma concentration-time curve to the end of dosing interval (AUCtau) of carbamazepine and carbamazepine metabolites following oral dosing of carbamazepine alone and in the presence of radiprodil | Blood samples for plasma PK will be collected on Days 18 and 25. |
| Part A: To assess the time to maximum observed plasma concentration (Tmax) of carbamazepine and carbamazepine metabolites following oral dosing of carbamazepine alone and in the presence of radiprodil | Blood samples for plasma PK will be collected on Days 18 and 25. |
| Part B: To assess the time to maximum observed plasma concentration (Tmax) of itraconazole following oral dosing of itraconazole alone and in the presence of radiprodil | Blood samples for plasma PK will be collected on Days 13 and 18. |
| Part B: To assess the maximum observed plasma concentration (Cmax) of itraconazole following oral dosing of itraconazole alone and in the presence of radiprodil | Blood samples for plasma PK will be collected on Days 13 and 18. |
| Part A: To assess the maximum observed plasma concentration (Cmax) of carbamazepine and carbamazepine metabolites following oral dosing of carbamazepine alone and in the presence of radiprodil | Blood samples for plasma PK will be collected on Days 18 and 25. |
| Number of participants with abnormal laboratory test results | The clinical laboratory tests include hematology, serum chemisty and coagulation | From Screening to Day 30 and follow up visit 30 days post last dose |
| To assess the Columbia-Suicide Severity Rating Scale (C-SSRS) scores | The C-SSRS is a validated tool designed to systematically evaluate the severity and intensity of suicidal ideation and behavior. | From Screening to Day 30 and follow up visit 30 days post last dose |
| 12-Lead ECG: Mean change from Baseline to End-of-Treatment in QT interval | From Screening to Day 30 and follow up visit 30 days post last dose |
| 12-Lead ECG: Mean change from Baseline to End-of-Treatment in PR interval | From Screening to Day 30 and follow up visit 30 days post last dose |
| 12-Lead ECG: Mean change from Baseline to End-of-Treatment in QRS interval | From Screening to Day 30 and follow up visit 30 days post last dose |
| Melbourne |
| Victoria |
| 3004 |
| Australia |
| ID | Term |
|---|---|
| D014402 | Tuberous Sclerosis |
| D000092222 | Focal Cortical Dysplasia |
| ID | Term |
|---|---|
| D006222 | Hamartoma |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D065703 | Malformations of Cortical Development, Group I |
| D054220 | Malformations of Cortical Development |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| C000626801 | radiprodil |
| D002220 | Carbamazepine |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |
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