Healthy SubjectsPhase 1NCT07166887

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

A Phase 1 study testing Tolvaptan in people with Healthy Subjects, run by Otsuka Beijing Research Institute.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

pharmacokinetics, pharmacological effects and safety of multi dose of 7.5mg Tolvaptan tablet in healthy male subjects Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Tolvaptan
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: 7 Jun 2011to 27 Jul 2011
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male, sign informed consent;
When signing the informed consent, the age range is 18-40 years old (including the upper and lower limits);
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);
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.

Who cannot join

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.
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.
Have a history, allergy or tendency to drugs and any other substances.
Known intolerance to components of the test drug, including lactose. For example, people with rare genetic galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
Various voiding disorders (frequent urination, or difficulty urinating, etc.).
People who smoke, drink or depend on other drugs.

Show all 18Show fewer

Blood donors had an equivalent amount of blood loss (>350 ml) during the 12 weeks prior to enrollment.
Participated in any drug trials within 12 weeks prior to enrollment.
People who have taken preventive or therapeutic drugs in the last 2 weeks.
Consumed grapefruit or foods containing grapefruit in the week prior to administration.
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).
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.
Quiet for more than 3 minutes, sitting resting pulse below 55 beats/min or more than 90 beats/min.
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.
Clinically significant 12-lead electrocardiogram abnormalities.
Clinically significant abnormalities in physical examination.
Positive for any of the serological tests for HIV antibodies, HBsAg, HCV antibodies and syphilis antibodies.
Other circumstances that the investigator determines may affect the subject's completion of the test.

About this study

Official title: Pharmacokinetics, Pharmacological Effects and Safety of Multi Dose of 7.5mg Tolvaptan Tablet in Healthy Male Subjects

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

Conditions: Healthy Subjects
Being tested: Tolvaptan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07166887
Study group	Role	What they receive
7.5mg Tolvaptan multi dosing group	Experimental	Not described Receives: Drug: Tolvaptan

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolvaptan Pharmacokinetic
peak concentration (Cmax)
Measured: - 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
Tolvaptan Pharmacokinetic
time to peak (Tmax)
Measured: 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
Tolvaptan Pharmacokinetic
area under the drug-time curve (AUC0-t and AUC0-∞)
Measured: 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
Tolvaptan Pharmacokinetic
elimination half-life (t1/2)
Measured: 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
Tolvaptan Pharmacokinetic
apparent clearance (CL/F)
Measured: 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
Tolvaptan Pharmacokinetic
apparent volume of distribution (Vd/F)
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201127 Jul 2011

First posted10 Sep 2025
Study start7 Jun 2011
Primary completion27 Jul 2011
Study completion27 Jul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07166887
Sponsor's protocol ID: 156-11-808-01
Status last verified: Aug 2025
First submitted: 22 Aug 2025
Last updated: 10 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Pharmacological Effects and Safety of Multi Dose of 7.5mg Tolvaptan Tablet in Healthy Male Subjects
ClinicalTrials.gov ID: NCT07166887
Acronym / sponsor ID: 156-11-808-01
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
Study start: 7 Jun 2011 (actual)
Primary completion: 27 Jul 2011 (actual)
Study completion: 27 Jul 2011 (actual)
First posted: 10 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
7.5mg Tolvaptan multi dosing group	Experimental	Drug: Tolvaptan

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Male, sign informed consent;
When signing the informed consent, the age range is 18-40 years old (including the upper and lower limits);
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);
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.

Key exclusion criteria (18 listed)

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.
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.
Have a history, allergy or tendency to drugs and any other substances.
Known intolerance to components of the test drug, including lactose. For example, people with rare genetic galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
Various voiding disorders (frequent urination, or difficulty urinating, etc.).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TolvaptanOne dose on the first day and one dose on days 3-9, for a total of eight doses.	Drug	7.5mg Tolvaptan multi dosing group

Primary outcome

Tolvaptan Pharmacokinetic
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
peak concentration (Cmax)
Tolvaptan Pharmacokinetic
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
time to peak (Tmax)
Tolvaptan Pharmacokinetic
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
area under the drug-time curve (AUC0-t and AUC0-∞)
Tolvaptan Pharmacokinetic
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
elimination half-life (t1/2)
Tolvaptan Pharmacokinetic
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
apparent clearance (CL/F)
Tolvaptan Pharmacokinetic
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
apparent volume of distribution (Vd/F)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
Derived from this study: PubMed 41357896Liu 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.
Individual participant dataSharing planned: Yes

Related trials for Healthy Subjects

Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
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Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
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Active, not recruitingPhase 1
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RecruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tolvaptan in people with Healthy Subjects, run by Otsuka Beijing Research Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolvaptan Pharmacokinetic (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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07166887, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.