NCT01014416CompletedPhase 1
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
Korea Otsuka Pharmaceutical Co., Ltd.1 site in 1 country46 target enrollmentStarted: January 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- PK parameters: AUC, Cmax, Tmax
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Arm 1
Experimental
Single dose, Tolvaptan 15mg or Placebo/day
Intervention: Tolvaptan 15mg or 30mg or 60mg or Placebo (Drug)
Arm 2
Experimental
Single dose, Tolvaptan 30mg or Placebo/day
Intervention: Tolvaptan 15mg or 30mg or 60mg or Placebo (Drug)
Arm 3
Experimental
Single dose, Tolvaptan 60mg or Placebo/day
Intervention: Tolvaptan 15mg or 30mg or 60mg or Placebo (Drug)
Outcomes
Primary Outcomes
PK parameters: AUC, Cmax, Tmax
Time Frame: 1 day
PD parameters: 24 hour fluid balance
Time Frame: 1 day
Safety: adverse event, body weight, physical examination, vital sign, ECG, clinical laboratory test
Time Frame: 4 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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