Tiny dose, big data: healthy volunteers help map RE104's journey through the body
NCT ID NCT07146191
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how a single tiny dose of RE104 moves through and leaves the body in 8 healthy adults. Researchers measured the drug and its breakdown products in blood, urine, and stool over at least a week. The goal was purely to understand absorption and elimination, not to treat any condition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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8 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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Oct 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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: * Between 18 and 55 years of age (inclusive), and a body mass index of 18-34 kg/m2. * Willing to take a drug with psychoactive properties * If female and of childbearing potential, agrees to use an acceptable method of birth control and is not planning to become pregnant before, during or within 90 days after the last dose of the study drug. * If male, must agree to use condom with spermicide during and up to 90 days after discharge." * Must agree to refrain from sperm or egg donation until 120 days post discharge. * Able to understand and adhere to study schedule and requirements and willing to sign an ICF * In good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening * Agrees to not participate in other research studies involving investigational medication or medical devices for the duration of the study Exclusion Criteria: * Active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder. * Medical condition or other concomitant condition or history rendering unsuitability for the study * Has used or intends to use prohibited medications * Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications * Has participated in another clinical study within 30 days and/or with a \[14C\] labeled study drug within 1 year prior to enrolling. * Is pregnant or has a female partner who is pregnant
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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PPD Inc.
Austin, Texas, 78744, United States
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