A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women

Study Identifier:
323-201-00007
ClinicalTrials.gov Identifier:
NCT07542847
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Study Details

Medical Condition
  • Healthy Volunteers
Study Drug
  • Drug: OPC-167832
  • Drug: Itraconazole
  • Drug: Carbamazepine
Date
Sep 2022 - Nov 2022
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Inclusion Criteria
  • Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive.
  • In good health at screening as determined by:
  • Medical history
  • Physical examination
  • ECG
  • Serum/urine chemistry, hematology, and serology tests
  • Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial
  • Exclusion Criteria
  • Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participants at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
  • History of drug and/or alcohol abuse (as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate to severe alcohol/substance use disorder) within 2 years prior to the screening visit.
  • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen, hepatitis C antibodies, and/or human immunodeficiency virus antibodies.
  • History of any clinically significant drug allergy or known or suspected hypersensitivity, to any component of the IMP including structurally related drugs (eg, tricyclic antidepressants), hereditary fructose intolerance (Part 1 only), or any of the excipients.
  • A positive urine alcohol test and/or urine drug screen for substances of abuse at the screening visit or upon check-in to the trial site.
  • Participants having taken an investigational drug within 30 days prior to the screening visit.
  • Any history of clinically significant hemorrhagic tendencies.
  • Having received a vaccine within 14 days prior to dosing
  • Any participant who, in the opinion of the investigator, should not participate in the trial.
  • Female participants who are breast-feeding or who have a positive pregnancy test result prior to receiving IMP.
  • Participants without a permanent physical residence.
  • History of suicide ideation or severe depression that, in the opinion of the investigator, would exclude the participant from participating in this trial (applicable to Part 2 only).
  • Note: Other protocol-specified inclusion/exclusion criteria may apply.

Protocol Summary

The purpose of this trial is to assess the potential for cytochrome P450 (CYP)-mediated drug-drug interactions (DDIs) with OPC-167832. The study is conducted in 2 parts: Part 1 assesses the potential effect of the CYP3A inhibitor itraconazole on the metabolism of OPC-167832 and Part 2 assesses the potential effect of the CYP3A inducer carbamazepine on the metabolism of OPC-167832 in healthy adult participants.

Study Locations

Location
Status
Location
ICON plc
Lenexa, Kansas, United States, 66219
Status
N/A
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Inclusion Criteria
  • Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive.
  • In good health at screening as determined by:
  • Medical history
  • Physical examination
  • ECG
  • Serum/urine chemistry, hematology, and serology tests
  • Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial
  • Exclusion Criteria
  • Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participants at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
  • History of drug and/or alcohol abuse (as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate to severe alcohol/substance use disorder) within 2 years prior to the screening visit.
  • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen, hepatitis C antibodies, and/or human immunodeficiency virus antibodies.
  • History of any clinically significant drug allergy or known or suspected hypersensitivity, to any component of the IMP including structurally related drugs (eg, tricyclic antidepressants), hereditary fructose intolerance (Part 1 only), or any of the excipients.
  • A positive urine alcohol test and/or urine drug screen for substances of abuse at the screening visit or upon check-in to the trial site.
  • Participants having taken an investigational drug within 30 days prior to the screening visit.
  • Any history of clinically significant hemorrhagic tendencies.
  • Having received a vaccine within 14 days prior to dosing
  • Any participant who, in the opinion of the investigator, should not participate in the trial.
  • Female participants who are breast-feeding or who have a positive pregnancy test result prior to receiving IMP.
  • Participants without a permanent physical residence.
  • History of suicide ideation or severe depression that, in the opinion of the investigator, would exclude the participant from participating in this trial (applicable to Part 2 only).
  • Note: Other protocol-specified inclusion/exclusion criteria may apply.

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