Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults
PHASE1TERMINATED
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06965881
Intervention or treatment
DRUG: Radiprodil with Carbamazepine
DRUG: Radiprodil with Itraconazole
Conditions
- Tuberous Sclerosis Complex (TSC)
- Focal Cortical Dysplasia
- Other Neurological Disorders
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Research sites nearby
Closest Location:
Q-Pharm Pty Ltd
Select from list below to view details:
Q-Pharm Pty Ltd
Brisbane, Queensland, Australia
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
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Who is running the clinical trial?
GTI
GRIN Therapeutics, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Part A: Radiprodil with Carbamazepine
| Drug: Radiprodil with Carbamazepine |
EXPERIMENTAL: Part B: Radiprodil with Itraconazole
| Drug: Radiprodil with Itraconazole |
What is the study measuring?
Primary Outcome
| 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 | Not Specified | 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 | Not Specified | 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) | Not Specified | 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) | Not Specified | 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 | Not Specified | 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 | Not Specified | Blood samples will be collected Days 5 to 9 and 18 to 22 |
Secondary Outcome
| 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 |
| 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | From Screening to Day 30 and follow up visit 30 days post last dose |
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References
Clinical Trials Gov: Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy AdultsOther trials to consider
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