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Scientists track experimental drug TAK-935 through the body
NCT ID NCT04992442
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are studying how the body absorbs, distributes, breaks down, and removes TAK-935, an experimental drug. The trial enrolls a small number of healthy adult men who receive TAK-935 by mouth and by intravenous infusion, including a radioactive-labeled version to track the drug's path. The goal is to measure how much of the oral drug reaches the bloodstream and how the body processes and excretes it.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TAK-935 (soticlestat), an experimental drug
- What this could lead to
- If successful, this study could provide information on how the body handles TAK-935, which may help guide future dosing in patients.
- What could go wrong
- This is a very small, early-stage study in healthy men, so the results may not apply to patients or women, and it does not test whether the drug works for any condition.
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
-
6 people
The number who actually took part.
- Started
-
Jul 2020
- Finished
-
Aug 2020
- 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
-
19 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. Weighs at least 50 kg and body mass index (BMI) ≥18.0 and ˂32.0 kg/m\^2 at Screening Visit. 2. Continuous nonsmoker who has not used nicotine-containing products (including vaping) for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting. 3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the Investigator or designee. Exclusion Criteria: 1. History or presence of cataracts or other clinically significant vision disturbances. 2. Abnormal and clinically significant ECG abnormality at Screening visit: * QT interval with Fridericia's correction method (QTcF) \>450 milliseconds (ms) confirmed with one repeat testing. 3. History or presence of gastritis, gastrointestinal tract, gastric bypass surgery, or hepatic disorder or other clinical condition which, in the opinion of the Investigator or designee, may affect the absorption, distribution, metabolism, or elimination of study drug. 4. Has a risk of suicide according to the Investigator's clinical judgment \[e.g., per Columbia-Suicide Severity Rating Scale (C-SSRS)\] or has made a suicide attempt in the previous year prior to Screening Visit. 5. Positive urine drug or alcohol results at screening or first check-in. 6. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or novel coronavirus 2019 (COVID-19). 7. Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg at Screening. 8. Seated HR is lower than 40 beats per minute (bpm) or higher than 99 bpm at Screening Visit. 9. Estimated creatinine clearance \<80 mL/min at Screening Visit. 10. Has tattoo(s) or scarring at or near the site of IV infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator. 11. Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing. 12. Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks prior to first dosing. 13. Has received radiolabeled substances or has been exposed to radiation sources within 12 months of first dosing or is likely to receive radiation exposure or radioisotopes within 12 months of first dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe \[i.e., weighted annual limit recommended by the International Commission on Radiological Protection (ICRP) of 3000 milli roentgen equivalent man (mrem)\]. 14. Unable to refrain from or anticipates the use of: 1. Any drug, including prescription and nonprescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study, including the Follow-up Period. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration. After the first dose of study drug, ibuprofen (up to 1.2 g per 24 hours) may be administered at the discretion of the Investigator or designee. Milk of Magnesia (i.e., magnesium hydroxide) (≤60 mL per day) may be administered to ensure defecation, at discretion of the Investigator or designee. 2. Any drugs known to be significant inducers of cytochrome P450 (CYP)3A4, CYP2C19 or uridine diphosphate glucuronosyltransferase (UGT), including St. John's Wort, within 28 days prior to the first dosing and throughout the study, including the Follow-up Period. Appropriate sources (e.g., Flockhart Table\^TM) will be consulted to confirm lack of PK/pharmacodynamic interaction with study drug(s). 3. Alcohol 15. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study. 16. Donation of blood or significant blood loss within 56 days prior to the first dosing. 17. Plasma donation within 7 days prior to the first dosing.
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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
Lincoln, Nebraska, 68502, United States
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