Health SubjectsPhase 1NCT07166796

a Phase I PK Study in Healthy Male Subjects. 2 Groups of Healthy Male Subjects

A Phase 1 study testing singe dose 15mg, single dose 30mg and single dose 60mg in people with Health 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.

Official record

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Trial summary

Tolvaptan oral administraction phase I PK clinical trial. Two groups of healthy male subjects. One group receives single dose of Tolvaptan. The other group receives multi dose of Tolvaptan. 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?: singe dose 15mg, single dose 30mg and single dose 60mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: No sites listed yet
Study dates: 1 Oct 2006to 31 Jan 2007
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

Healthy male volunteers.
Aged 18 to 40 years old.
Weight no less than 50kg and within the range of standard weight (body mass index between 19 and 24).
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.
Signed the informed consent form.

Who cannot join

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.
Hepatitis B virus, syphilis, hepatitis C virus, HIV infection.
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.
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.
Quiet for more than 3 minutes, sitting 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; Diastolic depression of 60mmHg or higher than 90mmHg.

Show all 14Show fewer

Various voiding disorders (frequent urination, or difficulty urinating, etc.).
Have a family history of genetic diseases (including a history of genetically predisposed arrhythmias in relatives).
A history, allergy or propensity to be allergic to drugs or any other substance.
Smokers, alcoholics, or other drug addicts.
Physical examination had clinically significant positive findings.
People who have donated blood or been sampled as a subject within the last 3 months.
People who have taken prophylactic or therapeutic drugs in the last 2 weeks.
Otherwise, the clinical trial physician or the clinical trial physician determines that the safety of the trial is affected.

About this study

Official title: Tolvaptan Oral Administration Phase I Clinical Trial

Tolvaptan oral administraction phase I PK clinical trial. Two groups of healthy male subjects. One group receives single dose of Tolvaptan. The other group receives multi dose of Tolvaptan.

Conditions: Health Subjects
Being tested: singe dose 15mg, single dose 30mg, single dose 60mg, single dose 120mg, multi dose 30mg

What participants receive

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

singe dose 15mgDrug
succesfule screened subject, take single dose of 15mg Tolvaptan tablet with no feeding.
single dose 30mgDrug
succesfule screened subject, take single dose of 30mg Tolvaptan tablet with no feeding.
single dose 60mgDrug
succesfule screened subject, take single dose of 60mg Tolvaptan tablet with no feeding.
single dose 120mgDrug
succesfule screened subject, take single dose of 120mg Tolvaptan tablet with no feeding.
multi dose 30mgDrug
radomize 24 healthy adult male to 2 groups, 12 subjects each. One group take 30mg Tolvaptan. First day, with no feeding, take single 30mg dose, then start from day 3rd, take medication for 7 days. 8 days treatment in total.
multi dose 60mgDrug
radomize 24 healthy adult male to 2 groups, 12 subjects each. One group take 60mg Tolvaptan. First day, with no feeding, take single 60mg dose, then start from day 3rd, take medication for 7 days. 8 days treatment in total.

Study groups in NCT07166796
Study group	Role	What they receive
single dose	Experimental	Not described Receives: Drug: singe dose 15mg; Drug: single dose 30mg; Drug: single dose 60mg; Drug: single dose 120mg
multi dose	Experimental	Not described Receives: Drug: multi dose 30mg; Drug: multi dose 60mg

What is being measured

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

single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
peak concentration (Cmax)
Measured: Day 1 pre-dose and post-dose 0.5hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
peak concentration (Cmax)
Measured: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point.
single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
time to peak (Tmax)
Measured: Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
area under the drug-time curve (AUC0-t and AUC0-∞)
Measured: Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
elimination half-life (t1/2)
Measured: Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
apparent clearance (CL/F)
Measured: Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
apparent volume of distribution (Vd/F)
Measured: Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
time to peak (Tmax)
Measured: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
area under the drug-time curve (AUC0-t and AUC0-∞)
Measured: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
elimination half-life (t1/2)
Measured: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
apparent clearance (CL/F)
Measured: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
apparent volume of distribution (Vd/F)
Measured: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point

Timeline

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

1 Oct 200631 Jan 2007

First posted10 Sep 2025
Study start1 Oct 2006
Primary completion31 Jan 2007
Study completion31 Jan 2007

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07166796
Sponsor's protocol ID: 156-06-801-01
Status last verified: Aug 2025
First submitted: 25 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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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: Tolvaptan Oral Administration Phase I Clinical Trial
ClinicalTrials.gov ID: NCT07166796
Acronym / sponsor ID: 156-06-801-01
Conditions: Health Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital
Study start: 1 Oct 2006 (actual)
Primary completion: 31 Jan 2007 (actual)
Study completion: 31 Jan 2007 (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.

Tolvaptan oral administraction phase I PK clinical trial. Two groups of healthy male subjects. One group receives single dose of Tolvaptan. The other group receives multi dose of Tolvaptan.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
single dose	Experimental	Drug: singe dose 15mg, Drug: single dose 30mg, Drug: single dose 60mg, Drug: single dose 120mg
multi dose	Experimental	Drug: multi dose 30mg, Drug: multi dose 60mg

Who may qualify

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

Key inclusion criteria (5 listed)

Healthy male volunteers.
Aged 18 to 40 years old.
Weight no less than 50kg and within the range of standard weight (body mass index between 19 and 24).
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.
Signed the informed consent form.

Key exclusion criteria (14 listed)

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.
Hepatitis B virus, syphilis, hepatitis C virus, HIV infection.
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.
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.
Quiet for more than 3 minutes, sitting pulse below 55 beats/min or more than 90 beats/min.

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
singe dose 15mgsuccesfule screened subject, take single dose of 15mg Tolvaptan tablet with no feeding.	Drug	single dose
single dose 30mgsuccesfule screened subject, take single dose of 30mg Tolvaptan tablet with no feeding.	Drug	single dose
single dose 60mgsuccesfule screened subject, take single dose of 60mg Tolvaptan tablet with no feeding.	Drug	single dose
single dose 120mgsuccesfule screened subject, take single dose of 120mg Tolvaptan tablet with no feeding.	Drug	single dose
multi dose 30mgradomize 24 healthy adult male to 2 groups, 12 subjects each. One group take 30mg Tolvaptan. First day, with no feeding, take single 30mg dose, then start from day 3rd, take medication for 7 days. 8 days treatment in total.	Drug	multi dose
multi dose 60mgradomize 24 healthy adult male to 2 groups, 12 subjects each. One group take 60mg Tolvaptan. First day, with no feeding, take single 60mg dose, then start from day 3rd, take medication for 7 days. 8 days treatment in total.	Drug	multi dose

Primary outcome

single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
Time frame: Day 1 pre-dose and post-dose 0.5hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
peak concentration (Cmax)
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
Time frame: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point.
peak concentration (Cmax)
single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
Time frame: Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
time to peak (Tmax)
Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
Time frame: Day 1 pre-dose and post-dose 0.5 hour, 1 ,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-∞)
single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
Time frame: Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
elimination half-life (t1/2)
single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
Time frame: Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
apparent clearance (CL/F)
single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107
Time frame: Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours
apparent volume of distribution (Vd/F)
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
Time frame: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point
time to peak (Tmax)
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
Time frame: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point
area under the drug-time curve (AUC0-t and AUC0-∞)
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
Time frame: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point
elimination half-life (t1/2)
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
Time frame: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point
apparent clearance (CL/F)
multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103
Time frame: Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point
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 singe dose 15mg, single dose 30mg and single dose 60mg 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 5 inclusion and 14 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?

single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107 (time frame: Day 1 pre-dose and post-dose 0.5hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours). The study lists 12 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 NCT07166796, 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.