Tolvaptan drug levels measured in healthy volunteers
NCT ID NCT07166796
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-phase trial studied how the drug Tolvaptan is processed in the body. 64 healthy men received either a single dose or multiple doses of Tolvaptan. Researchers measured drug levels in the blood to understand its pharmacokinetics.
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
-
64 people
The number who actually took part.
- Started
-
Oct 2006
- Finished
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Jan 2007
- 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. Healthy male volunteers. 2. Aged 18 to 40 years old. 3. Weight no less than 50kg and within the range of standard weight (body mass index between 19 and 24). 4. Auxiliary examinations: blood routine and coagulation, urine routine, blood biochemistry (total protein, albumin, blood glucose, total bilirubin, AST (GOT), ALT (GPT), ALP, γ-GTP, LDH, CK (CPK), total cholesterol, triglycerides, urea nitrogen, creatinine, uric acid, Na, K, Cl, Mg, Ca, P), hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody, 12-lead electrocardiogram, 24-hour ambulatory electrocardiogram (Holter) examination, all items are normal. 5. Signed the informed consent form. Exclusion Criteria: 1. The patient has a history of heart, liver, kidney, digestive tract, metabolic, respiratory, blood, mental, nervous system and other disorders, and the doctor's judgment is not suitable. 2. Hepatitis B virus, syphilis, hepatitis C virus, HIV infection. 3. Patients with a history of clinically significant arrhythmias of various types, including rapid and slow types, such as atrioventricular block, sinus arrest, and supraventricular tachycardia, were assessed by the investigators. 4. He has a history of postural hypotension (blood pressure drop ≥20/10mmHg when he changes from lying position to standing position, accompanied by dizziness and other symptoms), standing dizziness, collapse, fainting, and vertigo. 5. Quiet for more than 3 minutes, sitting pulse below 55 beats/min or more than 90 beats/min. 6. Quiet for more than 3 minutes, sitting systolic blood pressure is lower than 100mmHg or higher than 140mmHg; Diastolic depression of 60mmHg or higher than 90mmHg. 7. Various voiding disorders (frequent urination, or difficulty urinating, etc.). 8. Have a family history of genetic diseases (including a history of genetically predisposed arrhythmias in relatives). 9. A history, allergy or propensity to be allergic to drugs or any other substance. 10. Smokers, alcoholics, or other drug addicts. 11. Physical examination had clinically significant positive findings. 12. People who have donated blood or been sampled as a subject within the last 3 months. 13. People who have taken prophylactic or therapeutic drugs in the last 2 weeks. 14. Otherwise, the clinical trial physician or the clinical trial physician determines that the safety of the trial is affected.
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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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