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

This study has been completed.
Sponsor:
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01014416
First received: November 3, 2009
Last updated: March 10, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:
  • PK parameters: AUC, Cmax, Tmax [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • PD parameters: 24 hour fluid balance [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Safety: adverse event, body weight, physical examination, vital sign, ECG, clinical laboratory test [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Single dose, Tolvaptan 15mg or Placebo/day
Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo
Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day
Experimental: Arm 2
Single dose, Tolvaptan 30mg or Placebo/day
Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo
Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day
Experimental: Arm 3
Single dose, Tolvaptan 60mg or Placebo/day
Drug: Tolvaptan 15mg or 30mg or 60mg or Placebo
Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014416

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
Principal Investigator: Kyung-Sang Yu, MD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: SungWoo Hong, Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01014416     History of Changes
Other Study ID Numbers: 156-KOA-0801
Study First Received: November 3, 2009
Last Updated: March 10, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
Healthy Korean male

ClinicalTrials.gov processed this record on August 19, 2014