Healthy Participants
Conditions
Brief summary
To investigate the safety, pharmacokinetics and pharmacodynamics when administering a single dose of TS-143 to Japanese healthy adult males using a placebo-controlled, double-blind, dose-ascending study, in addition to the effects of meals.
Interventions
DRUGTS-143
DRUGPlacebo
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
1. Subjects with a body-mass index (BMI) of 18.5 to less than 25.0 at the time of the screening tests 2. 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 prior to the investigational drug treatment
Exclusion criteria
1. Subjects who meet any of the following criteria in the screening tests or the tests conducted on Day -1 and prior to the investigational drug treatment * Red blood cell count: ≥ 535 × 10\^4 /μL * Hemoglobin: ≥ 16.2 g/dL * Hematocrit: ≥ 47.5% * Reticulocyte ratio: Outside of the reference value range 2. Subjects who meet any of the following criteria in the screening tests * Serum EPO concentration: Outside of the reference value range * Ferritin: 30 ng/mL or less, or ≥ 262 ng/mL 3. Subjects who meet any of the following criteria in the vital signs in the screening tests and the tests conducted prior to the investigational drug treatment * Blood pressure: Systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg or more * Pulse rate: \< 40 bpm, or ≥ 100 bpm * Body temperature: ≥ 37.5°C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 8 days | To evaluate the safety of TS-143 given single administration in healthy volunteers by incidence of adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters. |
| Plasma concentrations of unchanged form (ng/mL) | 72 hours | The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing. |
| Urinary excretions of unchanged form (ng/mL) | 72 hours | The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) for the total urinary excretion (amount and fraction) were summarized by dose group. |
| Serum erythropoietin (EPO) concentration | 72 hours | — |
Countries
Japan
Outcome results
None listed