Healthy Adult ParticipantsPhase 1NCT07884734
A Study to Evaluate the Effect of Carbamazepine or Itraconazole on Radiprodil in Healthy Adult Participants
A Phase 1 study testing Radiprodil, Carbamazepine and Itraconazole (200 mg) in people with Healthy Adult Participants, run by GRIN Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Radiprodil, Carbamazepine and Itraconazole (200 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2026to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group (CCTMG)
Glendale, California, 91206
About this study
Official title: A Phase 1, Open-Label, 2-Part Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of a CYP3A4 Inducer (Carbamazepine) or Inhibitor (Itraconazole) With Radiprodil in Healthy Adult Participants
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.
Read the detailed description
Part A will evaluate the effect of carbamazepine on the plasma pharmacokinetic profile of radiprodil. Participants will receive a single 30 mg oral dose of radiprodil under fed conditions, followed by multiple oral doses of carbamazepine, and then coadministration of radiprodil 30 mg with carbamazepine 300 mg.
Part B will evaluate the effect of itraconazole on the plasma pharmacokinetic profile of radiprodil. Participants will receive a single 15 mg oral dose of radiprodil under fed conditions, followed by multiple oral doses of itraconazole, and then coadministration of radiprodil 15 mg with itraconazole 200 mg.
- Conditions
- Healthy Adult Participants
- Being tested
- Radiprodil, Carbamazepine, Itraconazole (200 mg)
- Keywords
- Radiprodil, Carbamazepine, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiprodilDrug
Also called RGH-896, Radiprodil oral suspension
Radiprodil administered orally as a single dose of 30 mg in Part A or 15 mg in Part B under fed conditions.
CarbamazepineDrug
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)Drug
Itraconazole administered orally at 200 mg once daily in Part B to evaluate the effect of CYP3A4 inhibition on the pharmacokinetics of radiprodil.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Radiprodil With Carbamazepine | Experimental | Participants will receive a single oral dose of radiprodil 30 mg under fed conditions on Day 1. Carbamazepine will then be administered orally twice daily with food at escalating doses: 100 mg BID on Days 4 to 5, 200 mg BID on Days 6 to 7, and 300 mg BID on Days 8 to 15. On Day 16, radiprodil 30 mg will be coadministered with carbamazepine 300 mg under fed conditions. Carbamazepine 300 mg BID will continue on Days 17 to 18. Participants will be discharged on Day 21 and attend a follow-up visit 30 days ± 2 days after the last carbamazepine dose. Receives: Drug: Radiprodil; Drug: Carbamazepine |
| Part B: Radiprodil With Itraconazole | Experimental | Participants will receive a single oral dose of radiprodil 15 mg under fed conditions on Day 1. Itraconazole 200 mg once daily will be administered orally with food on Days 4 to 8. On Day 9, radiprodil 15 mg will be coadministered with itraconazole 200 mg under fed conditions. Itraconazole 200 mg once daily will continue on Days 10 to 11. Participants will be discharged on Day 12 and attend a follow-up visit 30 days ± 2 days after the last itraconazole dose. Receives: Drug: Radiprodil; Drug: Itraconazole (200 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of Radiprodil - Part A
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.
Measured: Part A: Day 1 through Day 19
AUCinf of Radiprodil - Part A
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.
Measured: Part A: Day 1 through Day 19
Cmax of Radiprodil - Part A
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.
Measured: Part A: Day 1 through Day 19
AUClast of Radiprodil - Part B
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.
Measured: Part B: Day 1 through Day 12
AUCinf of Radiprodil - Part B
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.
Measured: Part B: Day 1 through Day 12
Cmax of Radiprodil - Part B
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.
Measured: Part B: Day 1 through Day 12
Secondary outcomes (28)
AUClast of Carbamazepine - Part A
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration of carbamazepine following administration alone and in combination with radiprodil.
Measured: Part A: Day 16 (up to 12 hours post-dose)
AUCtau of Carbamazepine - Part A
Area under the plasma concentration-time curve over the 12-hour dosing interval (AUCtau) of carbamazepine following coadministration with radiprodil.
Measured: Part A: Day 16 (up to 12 hours post-dose)
Cmax of Carbamazepine - Part A
Maximum observed plasma concentration (Cmax) of carbamazepine following coadministration with radiprodil.
Measured: Part A: Day 16 (up to 12 hours post-dose)
Tmax of Carbamazepine - Part A
Time to reach maximum observed plasma concentration of carbamazepine following administration alone and in combination with radiprodil.
Measured: Part A: Day 16 (up to 12 hours post-dose)
AUClast of Itraconazole - Part B
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration of itraconazole following administration alone and in combination with radiprodil.
Measured: Part B: Day 9 through Day 10 (up to 24 hours post-dose)
AUCtau of Itraconazole - Part B
Area under the plasma concentration-time curve over the dosing interval of itraconazole following administration alone and in combination with radiprodil.
Measured: Part B: Day 9 through Day 10 (up to 24 hours post-dose)
Cmax of Itraconazole - Part B
Maximum observed plasma concentration of itraconazole following administration alone and in combination with radiprodil.
Measured: Part B: Day 9 through Day 10 (up to 24 hours post-dose)
Tmax of Itraconazole - Part B
Time to reach maximum observed plasma concentration of itraconazole following administration alone and in combination with radiprodil.
Measured: Part B: Day 9 through Day 10 (up to 24 hours post-dose)
Tmax of Radiprodil - Part A
Time to reach maximum observed plasma concentration of radiprodil. Assessed following administration of radiprodil alone and in combination with carbamazepine.
Measured: Part A: Day 1 through Day 19
Terminal Elimination Half-Life (t½) of Radiprodil - Part A
Terminal elimination half-life of radiprodil, defined as the time required for plasma concentration to decrease by half during the terminal elimination phase. Assessed following administration of radiprodil alone and in combination with carbamazepine.
Measured: Part A: Day 1 through Day 19
Apparent Total Body Clearance (CL/F) of Radiprodil - Part A
Apparent total body clearance of radiprodil following oral administration. Assessed following administration of radiprodil alone and in combination with carbamazepine.
Measured: Part A: Day 1 through Day 19
Apparent Volume of Distribution (Vz/F) of Radiprodil - Part A
Apparent volume of distribution of radiprodil during the terminal elimination phase following oral administration. Assessed following administration of radiprodil alone and in combination with carbamazepine.
Measured: Part A: Day 1 through Day 19
Tmax of Radiprodil - Part B
Time to reach maximum observed plasma concentration of radiprodil. Assessed following administration of radiprodil alone and in combination with itraconazole.
Measured: Part B: Day 1 through Day 12
Terminal Elimination Half-Life (t½) of Radiprodil - Part B
Terminal elimination half-life of radiprodil, defined as the time required for plasma concentration to decrease by half during the terminal elimination phase. Assessed following administration of radiprodil alone and in combination with itraconazole.
Measured: Part B: Day 1 through Day 12
Apparent Total Body Clearance (CL/F) of Radiprodil - Part B
Apparent total body clearance of radiprodil following oral administration. Assessed following administration of radiprodil alone and in combination with itraconazole.
Measured: Part B: Day 1 through Day 12
Apparent Volume of Distribution (Vz/F) of Radiprodil - Part B
Apparent volume of distribution of radiprodil during the terminal elimination phase following oral administration. Assessed following administration of radiprodil alone and in combination with itraconazole.
Measured: Part B: Day 1 through Day 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number and percentage of participants with at least one treatment-emergent adverse event (TEAE), summarised by treatment period and overall for each study part. TEAEs are adverse events occurring or worsening after the first dose of study drug.
Measured: From first dose of study drug through follow-up (up to approximately 90 days in Part A and 69 days in Part B)
Number of Participants With Serious Adverse Events (SAEs)
Number of participants experiencing at least one serious adverse event, summarised separately for each study part.
Measured: From signing of informed consent through follow-up (up to approximately 90 days in Part A and 69 days in Part B)
Change From Baseline in Systolic Blood Pressure
Change from baseline in systolic blood pressure, measured in mmHg, summarised by scheduled assessment time point and treatment period within each study part.
Measured: From baseline through follow-up
Change From Baseline in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure, measured in mmHg, summarised by scheduled assessment time point and treatment period within each study part.
Measured: From baseline through follow-up
Change From Baseline in Pulse Rate
Change from baseline in pulse rate, measured in beats per minute, summarised by scheduled assessment time point and treatment period within each study part.
Measured: From baseline through follow-up
Change From Baseline in Body Temperature
Change from baseline in body temperature, measured in degrees Celsius, summarised by scheduled assessment time point and treatment period within each study part.
Measured: From baseline through follow-up
Change From Baseline in Respiratory Rate
Change from baseline in respiratory rate, measured in breaths per minute, summarised by scheduled assessment time point and treatment period within each study part.
Measured: From baseline through follow-up
Number of Participants With QTcF Interval Above 450 Milliseconds
Number of participants with a QT interval corrected using Fridericia's formula (QTcF) greater than 450 milliseconds during the study.
Measured: From baseline through follow-up
Number of Participants With QTcF Interval Above 480 Milliseconds
Number of participants with a QTcF interval greater than 480 milliseconds during the study.
Measured: From baseline through follow-up
Number of Participants With QTcF Interval Above 500 Milliseconds
Number of participants with a QTcF interval greater than 500 milliseconds during the study.
Measured: From baseline through follow-up
Number of Participants With QTcF Increase From Baseline of at Least 30 Milliseconds
Number of participants with an increase in QTcF from baseline of at least 30 milliseconds during the study.
Measured: From baseline through follow-up
Number of Participants With QTcF Increase From Baseline of at Least 60 Milliseconds
Number of participants with an increase in QTcF from baseline of at least 60 milliseconds during the study.
Measured: From baseline through follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start8 Jun 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GRIN Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884734
- Sponsor's protocol ID
- RAD-GRIN-508
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 2-Part Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of a CYP3A4 Inducer (Carbamazepine) or Inhibitor (Itraconazole) With Radiprodil in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07884734
- Acronym / sponsor ID
- RAD-GRIN-508
- Conditions
- Healthy Adult Participants
- Keywords
- Radiprodil, Carbamazepine, Itraconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- GRIN Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Part A will evaluate the effect of carbamazepine on the plasma pharmacokinetic profile of radiprodil. Participants will receive a single 30 mg oral dose of radiprodil under fed conditions, followed by multiple oral doses of carbamazepine, and then coadministration of radiprodil 30 mg with carbamazepine 300 mg.
Part B will evaluate the effect of itraconazole on the plasma pharmacokinetic profile of radiprodil. Participants will receive a single 15 mg oral dose of radiprodil under fed conditions, followed by multiple oral doses of itraconazole, and then coadministration of radiprodil 15 mg with itraconazole 200 mg.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Radiprodil With Carbamazepine | Experimental | Drug: Radiprodil, Drug: CarbamazepineParticipants will receive a single oral dose of radiprodil 30 mg under fed conditions on Day 1. Carbamazepine will then be administered orally twice daily with food at escalating doses: 100 mg BID on Days 4 to 5, 200 mg BID on Days 6 to 7, and 300 mg BID on Days 8 to 15. On Day 16, radiprodil 30 mg will be coadministered with carbamazepine 300 mg under fed conditions. Carbamazepine 300 mg BID will continue on Days 17 to 18. Participants will be discharged on Day 21 and attend a follow-up visit 30 days ± 2 days after the last carbamazepine dose. |
| Part B: Radiprodil With Itraconazole | Experimental | Drug: Radiprodil, Drug: Itraconazole (200 mg)Participants will receive a single oral dose of radiprodil 15 mg under fed conditions on Day 1. Itraconazole 200 mg once daily will be administered orally with food on Days 4 to 8. On Day 9, radiprodil 15 mg will be coadministered with itraconazole 200 mg under fed conditions. Itraconazole 200 mg once daily will continue on Days 10 to 11. Participants will be discharged on Day 12 and attend a follow-up visit 30 days ± 2 days after the last itraconazole dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiprodilAlso: RGH-896, Radiprodil oral suspensionRadiprodil administered orally as a single dose of 30 mg in Part A or 15 mg in Part B under fed conditions. | Drug | Part A: Radiprodil With Carbamazepine, Part B: Radiprodil With Itraconazole |
| CarbamazepineCarbamazepine 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. | Drug | Part A: Radiprodil With Carbamazepine |
| 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. | Drug | Part B: Radiprodil With Itraconazole |
Primary outcome
AUClast of Radiprodil - Part A
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
28 secondary outcomes
AUClast of Carbamazepine - Part A
Time frame: Part A: Day 16 (up to 12 hours post-dose)
AUCtau of Carbamazepine - Part A
Time frame: Part A: Day 16 (up to 12 hours post-dose)
Cmax of Carbamazepine - Part A
Time frame: Part A: Day 16 (up to 12 hours post-dose)
Tmax of Carbamazepine - Part A
Time frame: Part A: Day 16 (up to 12 hours post-dose)
AUClast of Itraconazole - Part B
Time frame: Part B: Day 9 through Day 10 (up to 24 hours post-dose)
AUCtau of Itraconazole - Part B
Time frame: Part B: Day 9 through Day 10 (up to 24 hours post-dose)
Cmax of Itraconazole - Part B
Time frame: Part B: Day 9 through Day 10 (up to 24 hours post-dose)
Tmax of Itraconazole - Part B
Time frame: Part B: Day 9 through Day 10 (up to 24 hours post-dose)
Tmax of Radiprodil - Part A
Time frame: Part A: Day 1 through Day 19
Terminal Elimination Half-Life (t½) of Radiprodil - Part A
Time frame: Part A: Day 1 through Day 19
Apparent Total Body Clearance (CL/F) of Radiprodil - Part A
Time frame: Part A: Day 1 through Day 19
Apparent Volume of Distribution (Vz/F) of Radiprodil - Part A
Time frame: Part A: Day 1 through Day 19
Tmax of Radiprodil - Part B
Time frame: Part B: Day 1 through Day 12
Terminal Elimination Half-Life (t½) of Radiprodil - Part B
Time frame: Part B: Day 1 through Day 12
Apparent Total Body Clearance (CL/F) of Radiprodil - Part B
Time frame: Part B: Day 1 through Day 12
Apparent Volume of Distribution (Vz/F) of Radiprodil - Part B
Time frame: Part B: Day 1 through Day 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug through follow-up (up to approximately 90 days in Part A and 69 days in Part B)
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From signing of informed consent through follow-up (up to approximately 90 days in Part A and 69 days in Part B)
Change From Baseline in Systolic Blood Pressure
Time frame: From baseline through follow-up
Change From Baseline in Diastolic Blood Pressure
Time frame: From baseline through follow-up
Change From Baseline in Pulse Rate
Time frame: From baseline through follow-up
Change From Baseline in Body Temperature
Time frame: From baseline through follow-up
Change From Baseline in Respiratory Rate
Time frame: From baseline through follow-up
Number of Participants With QTcF Interval Above 450 Milliseconds
Time frame: From baseline through follow-up
Number of Participants With QTcF Interval Above 480 Milliseconds
Time frame: From baseline through follow-up
Number of Participants With QTcF Interval Above 500 Milliseconds
Time frame: From baseline through follow-up
Number of Participants With QTcF Increase From Baseline of at Least 30 Milliseconds
Time frame: From baseline through follow-up
Number of Participants With QTcF Increase From Baseline of at Least 60 Milliseconds
Time frame: From baseline through follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiprodil, Carbamazepine and Itraconazole (200 mg) in people with Healthy Adult Participants, run by GRIN Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUClast of Radiprodil - Part A (time frame: Part A: Day 1 through Day 19). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.