Healthy Participants
Conditions
Brief summary
To investigate the safety, pharmacokinetics and pharmacodynamics of TS-143 when administered 3 times a day for 10 days to healthy Japanese adult males using placebo-controlled, double-blind, dose escalation study design.
Interventions
DRUGTS-143
Subjects should take 4 capsules once and 3 times per day in step 1. Subjects should take 2 capsules once and 3 times per day in step 2.
DRUGPlacebo
Subjects should take 4 capsules once and 3 times per day in step 1. Subjects should take 2 capsules once and 3 times per day in step 2.
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects with a BMI of 18.5 to less than 25.0 at the time of the screening tests * Subjects judged by the principal investigator or a subinvestigator to be appropriate for participation in the study based on the results of the screening tests and the tests conducted before the investigational drug treatment on Day 1 * Subjects capable of receiving an explanation of this study before participation, understanding the details, and providing written informed consent themselves
Exclusion criteria
1. Subjects meeting any of the following criteria in the results of screening tests, tests conducted on the day before the first investigational treatment (Day -1), and tests conducted before the investigational drug treatment on the morning of Day 1: * Red blood cell count: ≥535 × 10\^4 /μL * Hemoglobin: ≥16.2 g/dL * Hematocrit: ≥47.5% * Reticulocyte rate: Outside of the reference value range 2. Subjects meeting any of the following criteria in the screening tests: * Serum EPO concentration: Outside of the reference value range * Ferritin: ≤30 ng/mL or \>upper limit of the reference value 3. Subjects meeting any of the following criteria in the vital signs in the screening tests and the tests conducted before the investigational drug treatment on the morning of Day 1: * Blood pressure: Systolic blood pressure ≥140 mmHg, or diastolic blood pressure ≥90 mmHg * Pulse rate: \<40 bpm, or ≥100 bpm * Body temperature: ≥37.5°C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of subjects with adverse events | 18 days | To evaluate the safety of TS-143 given single administration in healthy volunteers by incidence of subjects with adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters. |
| Plasma concentrations of unchanged form (ng/mL) | 13 days | — |
| Urinary excretions of unchanged form (ng/mL) | 12 days | — |
| Serum EPO concentration | 13 days | — |
| Reticulocyte count | 13 days | — |
| Plasma vascular endothelial growth factor (VEGF) concentration | 13 days | — |
| Serum iron (μg／dL) | 13 days | — |
| Total iron binding capacity（μg／dL） | 13 days | — |
Countries
Japan
Outcome results
None listed