Health SubjectsPhase 1NCT07166783
Single Dose of 7.5mg Tolvaptan Phase I Clinical Trial Protocol
A Phase 1 study testing Tolvaptan in people with Health Subjects, run by Otsuka Beijing Research Institute.
Trial summary
Pharmacokinetics, pharmacological effects and safety of single 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
- Health Subjects
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2011to 4 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, signing the informed consent form;
- At the time of signing the informed consent form, aged between 18 and 40 years old (inclusive);
- Body weight no less than 50kg, body mass index within the range of 19 to 24 (inclusive);
- Proven to be a healthy subject based on the results of medical history, serological tests (HIV antibody, HBsAg, HCV antibody and syphilis antibody), physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram, and laboratory tests (blood routine, blood biochemistry, coagulation function and urine routine).
Who cannot join
- Those with a history of heart, liver, kidney, digestive tract, metabolic disorders, respiratory, blood, mental or nervous system diseases, or those judged by the physician as unsuitable.
- Those with a history of clinically significant arrhythmias of any type, including a family history of genetic diseases (relatives with a history of arrhythmias with genetic predisposition), such as rapid and slow types, including atrioventricular block, sinus arrest, supraventricular tachycardia, etc.
- Those with a history of drug or other substance allergies, allergic constitution or tendency.
- Those known to be intolerant to the components of the test drug (including lactose), such as those with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- Those with various urinary disorders (such as frequent urination or difficulty in urination, etc.).
- Those who smoke, are alcoholics or have other drug dependencies.
Show all 18Show fewer
- Those who have donated blood or lost an equivalent amount of blood (>350 ml) within 12 weeks before enrollment.
- Those who have participated in any drug trials within 12 weeks before enrollment.
- Those who have taken any preventive or therapeutic drugs within the past 2 weeks.
- Those who have consumed grapefruit or grapefruit-containing foods within one week before taking the drug.
- Those whose diet is significantly deviated from normal protein, carbohydrate and fat intake as judged by the investigator (such as vegetarians or absolute vegetarians).
- Those with a history of orthostatic hypotension (a drop in blood pressure of ≥20/10 mmHg when changing from a lying to a standing position, accompanied by symptoms such as dizziness), orthostatic dizziness, syncope, fainting or vertigo.
- Those whose resting pulse rate is less than 55 beats per minute or more than 90 beats per minute after sitting quietly for more than 3 minutes.
- Those whose sitting systolic blood pressure is less than 100 mmHg or more than 140 mmHg, or whose diastolic blood pressure is less than 60 mmHg or more than 90 mmHg after sitting quietly for more than 3 minutes.
- Those with clinically significant 12-lead electrocardiogram changes.
- Those with clinically significant physical examination abnormalities.
- Those with positive results for HIV antibody, HBsAg, HCV antibody or syphilis antibody tests.
- Other conditions judged by the researcher as potentially affecting the subject's completion of the trial.
About this study
Official title: Pharmacokinetics, Pharmacological Effects and Safety of Single Dose of 7.5mg Tolvaptan Tablet in Healthy Male Subjects
Pharmacokinetics, pharmacological effects and safety of single dose of 7.5mg Tolvaptan tablet in healthy male subjects
- Conditions
- Health Subjects
- Being tested
- Tolvaptan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
single dose oral administration of 7.5mg Tolvaptan
| Study group | Role | What they receive |
|---|---|---|
| 7.5mg Tolvaptan single dose | Experimental | Not described Receives: Drug: Tolvaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolvaptan PK parameter
peak concentration (Cmax)
Measured: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours.
Tolvaptan PK parameter
time to peak (Tmax)
Measured: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
Tolvaptan PK parameter
area under the drug-time curve (AUC0-t and AUC0-∞)
Measured: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
Tolvaptan PK parameter
elimination half-life (t1/2)
Measured: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
Tolvaptan PK parameter
apparent clearance (CL/F)
Measured: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
Tolvaptan PK parameter
apparent volume of distribution (Vd/F)
Measured: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start16 Jun 2011
- Primary completion4 Jul 2011
- Study completion4 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 Health 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166783
- Sponsor's protocol ID
- 156-11-807-01
- 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
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 Single Dose of 7.5mg Tolvaptan Tablet in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT07166783
- Acronym / sponsor ID
- 156-11-807-01
- Conditions
- Health Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2011 (actual)
- Primary completion
- 4 Jul 2011 (actual)
- Study completion
- 4 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 single 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 single dose | 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, signing the informed consent form;
- At the time of signing the informed consent form, aged between 18 and 40 years old (inclusive);
- Body weight no less than 50kg, body mass index within the range of 19 to 24 (inclusive);
- Proven to be a healthy subject based on the results of medical history, serological tests (HIV antibody, HBsAg, HCV antibody and syphilis antibody), physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram, and laboratory tests (blood routine, blood biochemistry, coagulation function and urine routine).
Key exclusion criteria (18 listed)
- Those with a history of heart, liver, kidney, digestive tract, metabolic disorders, respiratory, blood, mental or nervous system diseases, or those judged by the physician as unsuitable.
- Those with a history of clinically significant arrhythmias of any type, including a family history of genetic diseases (relatives with a history of arrhythmias with genetic predisposition), such as rapid and slow types, including atrioventricular block, sinus arrest, supraventricular tachycardia, etc.
- Those with a history of drug or other substance allergies, allergic constitution or tendency.
- Those known to be intolerant to the components of the test drug (including lactose), such as those with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- Those with various urinary disorders (such as frequent urination or difficulty in urination, 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 |
|---|---|---|
| Tolvaptansingle dose oral administration of 7.5mg Tolvaptan | Drug | 7.5mg Tolvaptan single dose |
Primary outcome
Tolvaptan PK parameter
Time frame: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours.
peak concentration (Cmax)
Tolvaptan PK parameter
Time frame: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
time to peak (Tmax)
Tolvaptan PK parameter
Time frame: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
area under the drug-time curve (AUC0-t and AUC0-∞)
Tolvaptan PK parameter
Time frame: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
elimination half-life (t1/2)
Tolvaptan PK parameter
Time frame: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
apparent clearance (CL/F)
Tolvaptan PK parameter
Time frame: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
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
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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 Health 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 PK parameter (time frame: On Day 1 pre-dose and post-dose 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours.). 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 NCT07166783, 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.