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Healthy volunteers help uncover drug safety secrets

NCT ID NCT07542847

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a new drug called OPC-167832 is processed by the liver when taken with other common medicines. Twenty-four healthy adults took part to see if certain drugs slow down or speed up the breakdown of OPC-167832. The goal was to gather safety information, not to treat any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • ICON plc

    Lenexa, Kansas, 66219, United States

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