Tolvaptan drug tested in healthy men for safety and body processing
NCT ID NCT07166887
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This completed Phase 1 trial tested the drug tolvaptan (7.5mg) in 12 healthy men to see how the body absorbs, processes, and eliminates it. Participants took the tablet eight times over nine days. The study measured drug levels in the blood and checked for side effects, but it was not designed 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
- tolvaptan
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
-
12 people
The number who actually took part.
- Started
-
Jun 2011
- Finished
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Jul 2011
- 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 40 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. Male, sign informed consent; 2. When signing the informed consent, the age range is 18-40 years old (including the upper and lower limits); 3. The body weight is not less than 50kg, and the body mass index is in the range of 19 \~ 24 (including the upper and lower limits); 4. According to the results of medical history, serological examination (HIV antibody, HBsAg, HCV antibody and syphilis antibody), physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram, laboratory examination (blood routine, blood biochemistry, coagulation function and urine routine), etc., the subjects are certified as healthy. Exclusion Criteria: 1. Patients with a history of heart, liver, kidney, digestive tract, metabolic, respiratory, blood, mental, nervous system and other disorders, and doctors judge that they are not suitable. 2. Patients with a history of various types of arrhythmias judged by the researchers to have clinical significance, including a history of familial genetic disease (a history of arrhythmias with a genetic tendency in relatives), and a history of rapid and slow arrhythmias, such as atrioventricular transmission Conduction block, sinus arrest, supraventricular tachycardia and so on. 3. Have a history, allergy or tendency to drugs and any other substances. 4. Known intolerance to components of the test drug, including lactose. For example, people with rare genetic galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. 5. Various voiding disorders (frequent urination, or difficulty urinating, etc.). 6. People who smoke, drink or depend on other drugs. 7. Blood donors had an equivalent amount of blood loss (\>350 ml) during the 12 weeks prior to enrollment. 8. Participated in any drug trials within 12 weeks prior to enrollment. 9. People who have taken preventive or therapeutic drugs in the last 2 weeks. 10. Consumed grapefruit or foods containing grapefruit in the week prior to administration. 11. In the investigator's judgment, the subject's diet deviates significantly from the normal intake of protein, carbohydrates, and fats (for example, vegetarian or vegan). 12. Have a history of postural hypotension (refers to a blood pressure drop of ≥20/10mmHg when the blood pressure changes from the lying position to the standing position, accompanied by dizziness and other symptoms), standing vertigo, collapse, syncopation, and vertigo. 13. Quiet for more than 3 minutes, sitting resting pulse below 55 beats/min or more than 90 beats/min. 14. Quiet for more than 3 minutes, sitting systolic blood pressure is lower than 100mmHg or higher than 140mmHg; Or diastolic depression of 60mmHg or more than 90mmHg. 15. Clinically significant 12-lead electrocardiogram abnormalities. 16. Clinically significant abnormalities in physical examination. 17. Positive for any of the serological tests for HIV antibodies, HBsAg, HCV antibodies and syphilis antibodies. 18. Other circumstances that the investigator determines may affect the subject's completion of the test.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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