AzTrials
AzTrials

Healthy VolunteersPhase 1NCT07542847

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

A Phase 1 study testing OPC-167832, Itraconazole and Carbamazepine in people with Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
OPC-167832, Itraconazole and Carbamazepine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
19 Sep 2022to 11 Dec 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ICON plc

    Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: 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.

Being tested
OPC-167832, Itraconazole, Carbamazepine
Keywords
Tuberculosis, TB
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OPC-167832Drug

    Oral tablets.

  • ItraconazoleDrug

    Oral solution.

  • CarbamazepineDrug

    Oral tablets.

Study groups in NCT07542847
Study groupRoleWhat they receive
Part 1: OPC-167832 and ItraconazoleExperimentalParticipants 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.
Receives: Drug: OPC-167832; Drug: Itraconazole
Part 2: OPC-167832 and CarbamazepineExperimentalParticipants 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.
Receives: Drug: OPC-167832; Drug: Carbamazepine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832

    Measured: Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15.

  2. Part 2: Cmax of OPC-167832

    Measured: Predose and up to 168 hours postdose on Day 1; and Predose and up to 168 hours postdose on Day 25.

  3. Part 1: Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of OPC-167832

    Measured: Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15.

  4. Part 2: AUCt of OPC-167832

    Measured: Predose and up to 168 hours postdose on Day 1; and Predose and up to 168 hours postdose on Day 25.

  5. Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of OPC-167832

    Measured: Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15.

  6. Part 2: AUCinfinity of OPC-167832

    Measured: Predose and upto 168 hours postdose on Day 1; and Predose and upto 168 hours postdose on Day 25.

Secondary outcomes (6)

  1. Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered a trial intervention and which does not necessarily have a causal relationship with this intervention. TEAEs are defined as AEs with an onset date on or after the start of IMP treatment.

    Measured: Part 1: Up to 8 weeks; Part 2: Up to 9 weeks

  2. Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters

    Clinical laboratory tests for serum chemistry, hematology, and urinalysis were measured. Clinical significance was determined by the investigator.

    Measured: Part 1: Up to 8 weeks; Part 2: Up to 9 weeks

  3. Parts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities

    Vital signs criteria for clinically significant changes: systolic blood pressure (greater than [>]160 millimeters of mercury [mmHg] to less than [<]90 mmHg), diastolic blood pressure (>105 mmHg to <50 mmHg), heart rate (>110 beats per minute [bpm] to <50 bpm), respiratory rate (<12 breaths/min or > 20 breaths/min), and temperature (<36 degree Celsius [°C] or >38°C).

    Measured: Part 1: Up to 8 weeks; Part 2: Up to 9 weeks

  4. Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Physical Examinations

    The physical examination included height (screening only), weight, and calculation of body mass index (BMI), as well as assessment of the head, neck, eyes, ears, nose, and throat; thorax; abdomen; skin and mucosae; neurological; and extremities. Clinical significance was determined by the investigator.

    Measured: Part 1: Up to 8 weeks; Part 2: Up to 9 weeks

  5. Parts 1 and 2: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Parameters

    Electrocardiogram measurements included heart rate (HR), PR, QRS, RR, QT, QTcF, QTcB). The participants were assessed based on the clinically relevant changes in ECG values as per criteria defined in SAP.

    Measured: Part 1: Up to 8 weeks; Part 2: Up to 9 weeks

  6. Part 2: Number of Participants With Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)

    The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation, suicidal behavior and non-suicidal self-injurious behavior. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, suicidal behavior, completed suicide), suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan and intent) and non-suicidal self-injurious behavior.

    Measured: Up to 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2026
  2. Study start19 Sep 2022
  3. Primary completion18 Nov 2022
  4. Study completion11 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07542847
Sponsor's protocol ID
323-201-00007
Status last verified
Jun 2026
First submitted
14 Apr 2026
Last updated
5 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OPC-167832, Itraconazole and Carbamazepine in people with Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832 (time frame: Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07542847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in