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

A Phase 1, Single-center, Two-part, Open-label, Pharmacokinetic Trial to Assess the Potential for Cytochrome P450 3A Mediated Drug-drug Interactions With Orally Administered OPC-167832 Tablets in Healthy Adult Subjects

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: OPC-167832; Drug: Itraconazole; Drug: Carbamazepine

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • ICON plc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

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

2. In good health at screening as determined by:

   1. Medical history
   2. Physical examination
   3. ECG
   4. Serum/urine chemistry, hematology, and serology tests
3. 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

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Participants having taken an investigational drug within 30 days prior to the screening visit.
7. Any history of clinically significant hemorrhagic tendencies.
8. Having received a vaccine within 14 days prior to dosing
9. Any participant who, in the opinion of the investigator, should not participate in the trial.
10. Female participants who are breast-feeding or who have a positive pregnancy test result prior to receiving IMP.
11. Participants without a permanent physical residence.
12. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: OPC-167832 and Itraconazole; Participants receive single OPC-167832 dose, orally on Days 1 and 15, and itraconazole, orally, twice daily (BID), on Day 8 followed by itraconazole, once daily (QD) from Day 9 to Day 25 of Part 1.	Drug: OPC-167832; Oral tablets.; Drug: Itraconazole; Oral solution.
Experimental: Part 2: OPC-167832 and Carbamazepine; Participants receive single OPC-167832 dose, orally on Days 1 and 25, and carbamazepine Dose 1, orally, BID from Day 8 to Day 10, followed by Dose 2, BID from Day 11 to Day 13, and Dose 3, BID from Day 14 to Day 31 of Part 2.	Drug: OPC-167832; Oral tablets.; Drug: Carbamazepine; Oral tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832	Up to Day 26
Part 2: Cmax of OPC-167832	Up to Day 32
Part 1: Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at time t (AUCt) of OPC-167832	Up to Day 26
Part 2: AUCt of OPC-167832	Up to Day 32
Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of OPC-167832	Up to Day 26
Part 2: AUCinfinity of OPC-167832	Up to Day 32

Secondary Outcome Measures

Outcome Measure	Time Frame
Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters	Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Vital Signs	Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Physical Examinations	Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters	Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
Part 2: Number of Participants With Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)	Part 2: Up to 9 weeks

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): November 18, 2022
• Study Completion (Actual): December 11, 2022

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Tuberculosis; TB
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Azoles; Triazoles; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Piperazines; Itraconazole; Carbamazepine
• Other Study ID Numbers: 323-201-00007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No