Congestive heart failure
Conditions
Interventions
investigational material(s)
Generic name etc : Tolvaptan Sodium Phosphate
INN of investigational material : -
Therapeutic category code : 213 Diuretics
Dosage and Administration for Investigational ma
Sponsors
Otsuka Pharmaceutical Co., LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese male subjects age 20 to 45 years, inclusive 2) Body Mass Index (BMI): at least 18.5 kg/m2 and less than 25.0 kg/m2 3) Subjects determined to have a genotype SLCO1B1 521T/T as a result of genetic testing for OATP1B1
Exclusion criteria
Exclusion criteria: Subjects with a history of clinically significant abnormality, or for whom a clinically significant abnormality is observed in the results of the screening examination, for which the investigator, subinvestigator, or sponsor judges that the abnormality could place the subject at risk or affect evaluation of drug absorption, distribution, metabolism, or excretion. Such abnormalities include, but are not limited to, a history or current symptoms of cardiac, hepatic, renal, nervous, endocrine, gastrointestinal, respiratory, hematologic, and immune diseases/disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics Assessments for Pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Assessments for Safety: adverse events (AEs), clinical laboratory tests, physical examination findings, vital signs (temperature, blood pressure, and pulse rate), body weight, and 12-lead electrocardiogram (ECG) | — |
Countries
Japan
Outcome results
None listed