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

NCT ID: NCT07166796

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-01
• Study Completion Date: 2007-01-31

Brief 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.

Conditions

Health Subjects

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single dose

Group Type: EXPERIMENTAL

singe dose 15mg

Intervention Type: DRUG

succesfule screened subject, take single dose of 15mg Tolvaptan tablet with no feeding.

single dose 30mg

Intervention Type: DRUG

succesfule screened subject, take single dose of 30mg Tolvaptan tablet with no feeding.

single dose 60mg

Intervention Type: DRUG

succesfule screened subject, take single dose of 60mg Tolvaptan tablet with no feeding.

single dose 120mg

Intervention Type: DRUG

succesfule screened subject, take single dose of 120mg Tolvaptan tablet with no feeding.

multi dose

Group Type: EXPERIMENTAL

multi dose 30mg

Intervention Type: DRUG

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 60mg

Intervention Type: DRUG

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.

Interventions

singe dose 15mg

succesfule screened subject, take single dose of 15mg Tolvaptan tablet with no feeding.

Intervention Type: DRUG

single dose 30mg

succesfule screened subject, take single dose of 30mg Tolvaptan tablet with no feeding.

Intervention Type: DRUG

single dose 60mg

succesfule screened subject, take single dose of 60mg Tolvaptan tablet with no feeding.

Intervention Type: DRUG

single dose 120mg

succesfule screened subject, take single dose of 120mg Tolvaptan tablet with no feeding.

Intervention Type: DRUG

multi dose 30mg

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.

Intervention Type: DRUG

multi dose 60mg

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: collaborator

Otsuka Beijing Research Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

156-06-801-01

Identifier Type: -

Identifier Source: org_study_id