Pharmacokinetics/Pharmacodynamics (PK/PD) Characteristics of Tolvaptan Tablet in Korean Healthy Male

Study Overview
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Brief Summary
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To investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of tolvaptan 15, 30 and 60 mg after single oral administration in healthy Korean male subjects.

Official Title
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A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalation Study to Investigate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Tolvaptan in Healthy Korean Male Subjects Bipolar Disorder

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Korean male subjects between 20 and 45 years of age, inclusive. Body Mass Index (BMI) of 20 to 26 kg/m2, body,weight ≥ 50kg BMI = weight (kg)/height2(m) Informed consent from the subjects Exclusion Criteria: Clinically significant abnormality of respiratory, cardiovascular, hepatic, neurologic, endocrine, hematologic, urinary, psychiatric. History of gastrointestinal disease or surgery which can affect intestinal absorption of the study drug. History of any significant drug allergy or hypersensitivity. AST or ALT > 1.25 times upper normal limit at screening clinical laboratory test Supine blood pressure after resting for ≥ 3 minutes, higher than 140/90 mmHg or lower than 100/50 mmHg, Supine pulse, after resting for ≥ 3 minutes, outside the range of 40 to 90 beats/minute. Subjects who had history of drug abuse or alcohol addiction Subjects who used of any prescription drug or herbal medication within 2 weeks prior to the first dosing of the study drug, or any over-the-counter or vitamin supplements within 1 week prior to the first dosing (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied) The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Single dose, Tolvaptan 15mg or Placebo/day | Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo<br>* Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day<br>|
| Experimental: Arm 2<br>Single dose, Tolvaptan 30mg or Placebo/day | Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo<br>* Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day<br>|
| Experimental: Arm 3<br>Single dose, Tolvaptan 60mg or Placebo/day | Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo<br>* Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters: AUC, Cmax, Tmax |  | 1 day | 
| PD parameters: 24 hour fluid balance |  | 1 day | 
| Safety: adverse event, body weight, physical examination, vital sign, ECG, clinical laboratory test |  | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Korean male