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

NCT01014416 | Completed Phase 1

• 1 other identifier: 156-KOA-0801
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy Korean male

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Arm 1

EXPERIMENTAL

Single dose, Tolvaptan 15mg or Placebo/day

Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo

Arm 2

EXPERIMENTAL

Single dose, Tolvaptan 30mg or Placebo/day

Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo

Arm 3

EXPERIMENTAL

Single dose, Tolvaptan 60mg or Placebo/day

Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo

Interventions

Tolvaptan 15mg or 30mg or 60mg or Placebo DRUG

Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Tolvaptan

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kyung-Sang Yu, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 17, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 11, 2010

Record last verified: 2010-03

Locations

KR (1)