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

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ClinicalTrials.gov Identifier: NCT01014416
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : March 11, 2010
Sponsor:
Information provided by:
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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Tolvaptan
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. PK parameters: AUC, Cmax, Tmax [ Time Frame: 1 day ]
  2. PD parameters: 24 hour fluid balance [ Time Frame: 1 day ]
  3. Safety: adverse event, body weight, physical examination, vital sign, ECG, clinical laboratory test [ Time Frame: 4 days ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: SungWoo Hong, Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01014416     History of Changes
Other Study ID Numbers: 156-KOA-0801
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: March 11, 2010
Last Verified: March 2010

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

Additional relevant MeSH terms:
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs