Healthy volunteers help uncover drug safety secrets
NCT ID NCT07542847
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.
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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 Hide 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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