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CompletedNCT07166887Updated Sep 10, 2025

Phase I Study Multi Dose of 7.5mg Tolvaptan in Health Male

A Phase 1 interventional study of Tolvaptan in Healthy Subjects, sponsored by Otsuka Beijing Research Institute. Completed. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Otsuka Beijing Research Institute (part of Otsuka Holdings Co., Ltd.) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 14 years 2 months after the study started (first participant enrolled Jun 2011, registered Aug 2025).

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Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

pharmacokinetics, pharmacological effects and safety of multi dose of 7.5mg Tolvaptan tablet in healthy male subjects

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

Otsuka Beijing Research Institute is the lead sponsor of 36 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male, sign ;
  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 is in the range of 19 \~ 24 (including the upper and lower limits);
  4. According to the results of medical history, serological examination ( antibody, , antibody and syphilis antibody), physical examination, vital signs (temperature, blood pressure, pulse), 12-lead , laboratory examination (blood routine, blood biochemistry, coagulation function and urine routine), etc., the subjects are certified as healthy.

Exclusion criteria

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. 12-lead abnormalities.
  16. Clinically significant abnormalities in physical examination.
  17. Positive for any of the serological tests for antibodies, , antibodies and syphilis antibodies.
  18. Other circumstances that the investigator determines may affect the subject's completion of the test.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    7.5mg Tolvaptan multi dosing group

    Drug: Tolvaptan

Interventions

  • One dose on the first day and one dose on days 3-9, for a total of eight doses.

06

What researchers measure

Primary outcomes

  1. Tolvaptan Pharmacokinetic

    peak concentration (Cmax)

    Time frame: - On Day 1: 0.5 hour before the first dose - the Day 9th pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, day 24 (only on Day 2 and Day 10th morning), 36 ( on Day 2 and Day 10th everning) and 48 hours - Day 4th to 8th day pre-dose

  2. Tolvaptan Pharmacokinetic

    time to peak (Tmax)

    Time frame: On Day 1: 0.5 hour before the first dose - the Day 9th pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, day 24 (only on Day 2 and Day 10th morning), 36 ( on Day 2 and Day 10th everning) and 48 hours - Day 4th to 8th day pre-dose

  3. Tolvaptan Pharmacokinetic

    area under the drug-time curve (AUC0-t and AUC0-∞)

    Time frame: On Day 1: 0.5 hour before the first dose - the Day 9th pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, day 24 (only on Day 2 and Day 10th morning), 36 ( on Day 2 and Day 10th everning) and 48 hours - Day 4th to 8th day pre-dose

  4. Tolvaptan Pharmacokinetic

    elimination half-life (t1/2)

    Time frame: On Day 1: 0.5 hour before the first dose - the Day 9th pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, day 24 (only on Day 2 and Day 10th morning), 36 ( on Day 2 and Day 10th everning) and 48 hours - Day 4th to 8th day pre-dose

  5. Tolvaptan Pharmacokinetic

    apparent clearance (CL/F)

    Time frame: On Day 1: 0.5 hour before the first dose - the Day 9th pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, day 24 (only on Day 2 and Day 10th morning), 36 ( on Day 2 and Day 10th everning) and 48 hours - Day 4th to 8th day pre-dose

  6. Tolvaptan Pharmacokinetic

    apparent volume of distribution (Vd/F)

    Time frame: On Day 1: 0.5 hour before the first dose - the Day 9th pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, day 24 (only on Day 2 and Day 10th morning), 36 ( on Day 2 and Day 10th everning) and 48 hours - Day 4th to 8th day pre-dose

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Liu H, Liu T, Liu M, Zheng X, Zhong W, Zhao Q, Jiang J, Hu P, Li Y. Clinical trial on the pharmacokinetics, pharmacodynamics and safety of tolvaptan in healthy Chinese males: an open-label, single and multiple dosage, parallel group study. Front Pharmacol. 2025 Nov 21;16:1713702. doi: 10.3389/fphar.2025.1713702. eCollection 2025. PubMed 41357896 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2011 to primary completion in Jul 2011, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2025
First posted
Sep 10, 2025
StartActual
Jun 7, 2011
Primary completionActual
Jul 27, 2011
CompletionActual
Jul 27, 2011
Last update
Sep 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07166887
Responsible party
Sponsor
First posted
Sep 10, 2025
Start date
Jun 7, 2011
Primary completion
Jul 27, 2011
Completion
Jul 27, 2011
Last update
Sep 10, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tolvaptan

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