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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06965881
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 GRIN Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Russell Chin
Principal Investigator Affiliation GRIN Therapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Tuberous Sclerosis Complex (TSC), Focal Cortical Dysplasia, Other Neurological Disorders
Additional 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.

Arms & Interventions

Arms

Experimental: Part A: Radiprodil with Carbamazepine

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

Experimental: Part B: Radiprodil with Itraconazole

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

Interventions

Drug: - Radiprodil with Carbamazepine

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.

Drug: - Radiprodil with Itraconazole

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nucleus Network Pty Ltd, Melbourne, Victoria, Australia

Status

Address

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004

Site Contact

Ofer Gonen

[email protected]

+61 1800243733

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