Scientists track radioactive drug through 8 healthy men
NCT ID NCT07314320
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 1 trial studied how a single dose of the experimental drug OPC-167832 is eliminated from the body. Eight healthy men took the drug, which was tagged with a tiny amount of radioactivity, and researchers measured how much came out in urine and stool. The goal was purely to understand the drug's journey, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OPC-167832 (a radioactive-labeled drug)
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
-
8 people
The number who actually took part.
- Started
-
Nov 2023
- Finished
-
Dec 2023
- 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
-
Male participants only
- 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 18 to 32 kilograms per square meter (kg/m\^2) (inclusive). 2. In good health as determined by: 1. Medical history 2. Physical examination 3. ECG 4. Serum/urine biochemistry, hematology, and serology tests. 3. Experience regular bowel movements (i.e., at least 1 every day) for 30 days prior to Day -1. 4. Agree to remain exclusively in the research unit for the defined period. 5. Agree to comply with the protocol restrictions and requirements. 6. 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. 7. Male participants and their female partners who commit to remaining abstinent from trial screening through 90 days after the dose of investigational medicinal product (IMP) or utilizing 2 different approved methods of birth control from trial screening through 90 days after the dose of IMP. 8. Commit to refraining from sperm donation from the screening visit through 90 days after the dose of IMP. Exclusion Criteria: 1. Clinically relevant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including distribution, metabolism, and excretion of drug. 2. History of drug and/or alcohol abuse within 2 years prior to screening. 3. History of or current hepatitis or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies. 4. History of any significant drug allergy or known or suspected hypersensitivity, to any component of the IMP. 5. Participants having taken OPC-167832 within 30 days prior to screening. 6. Participants having 5 half-lives or twice the duration of the biological effect, whichever is longer, of any IMP (inclusive of OPC-167832) within 30 days prior to screening. 7. Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months prior to screening. 8. Any participant who, in the opinion of the investigator, should not participate in the trial. Note: Other protocol-specified inclusion/exclusion criteria may apply.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Celerion, Inc
Lincoln, Nebraska, 68502, United States
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