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

NCT07542847 | Completed Phase 1 FDA Drug

• 1 other identifier: 323-201-00007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Tuberculosis; TB

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• 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

Study Arms (2)

Part 1: OPC-167832 and Itraconazole

EXPERIMENTAL

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; Drug: Itraconazole

Part 2: OPC-167832 and Carbamazepine

EXPERIMENTAL

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; Drug: Carbamazepine

Interventions

OPC-167832 DRUG

Oral tablets.

Part 1: OPC-167832 and Itraconazole; Part 2: OPC-167832 and Carbamazepine

Itraconazole DRUG

Oral solution.

Part 1: OPC-167832 and Itraconazole

Carbamazepine DRUG

Oral tablets.

Part 2: OPC-167832 and Carbamazepine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

ICON plc

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Itraconazole; Carbamazepine

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: September 19, 2022
• Primary Completion: November 18, 2022
• Study Completion: December 11, 2022
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)