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

Sponsor ID
323-201-00007
Clinicaltrials.gov ID
NCT07542847
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
323-201-00007
Trial Details
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Age
18 - 55 Years
Therapeutic Area
  • Healthy Volunteers
    • Sex
    Female & Male
    Trial Dates
    Sep 2022 - Nov 2022
    Healthy Volunteers
    Yes
    • 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.

    Study 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.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: OPC-167832
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    24
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Inclusion Criteria
    • 1. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive.

    Exclusion Criteria

    Inclusion and Exclusion 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.

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    ICON plc
    Lenexa, Kansas, United States, 66219
    Status
    N/A

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