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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo

• Registration Number: NCT01014416
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-15
• Study First Posted: 2009-11-17
• Study Start: 2010-01
• Status Verified: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-10
• Last Update Posted: 2010-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

Inclusion Criteria

1. Healthy Korean male subjects between 20 and 45 years of age, inclusive.
2. Body Mass Index (BMI) of 20 to 26 kg/m2, body,weight ≥ 50kg BMI = weight (kg)/height2(m)
3. Informed consent from the subjects

Exclusion Criteria

1. Clinically significant abnormality of respiratory, cardiovascular, hepatic, neurologic, endocrine, hematologic, urinary, psychiatric.
2. History of gastrointestinal disease or surgery which can affect intestinal absorption of the study drug.
3. History of any significant drug allergy or hypersensitivity.
4. AST or ALT > 1.25 times upper normal limit at screening clinical laboratory test
5. 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.
6. Subjects who had history of drug abuse or alcohol addiction
7. 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)
8. The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Tolvaptan 15mg or 30mg or 60mg or Placebo	Single dose, Tolvaptan 60mg or Placebo/day
Arm 2	Tolvaptan 15mg or 30mg or 60mg or Placebo	Single dose, Tolvaptan 30mg or Placebo/day
Arm 1	Tolvaptan 15mg or 30mg or 60mg or Placebo	Single dose, Tolvaptan 15mg or Placebo/day

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of