Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)
- Registration Number
- NCT03591133
- Lead Sponsor
- Taisho Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
- Subjects with a body-mass index (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 prior to the investigational drug treatment
-
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
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Step4:20㎎ QD Placebo Drug: TS-143 20mg Drug: Placebo Step2:6㎎ QD Placebo Drug: TS-143 6mg Drug: Placebo Step5:36㎎ QD TS-143 Drug: TS-143 36mg Drug: Placebo Step1:3㎎ QD Placebo Drug: TS-143 3mg Drug: Placebo Step1:3㎎ QD TS-143 Drug: TS-143 3mg Drug: Placebo Step3-1:11㎎ QD TS-143 Drug: TS-143 11mg Drug: Placebo Step3-2:11㎎ QD（Fed) TS-143 Drug: TS-143 11mg Drug: Placebo Step3-2:11㎎ QD（Fed) Placebo Drug: TS-143 11mg Drug: Placebo Step3-1:11㎎ QD Placebo Drug: TS-143 11mg Drug: Placebo Step5:36㎎ QD Placebo Drug: TS-143 36mg Drug: Placebo Step4:20㎎ QD TS-143 Drug: TS-143 20mg Drug: Placebo Step2:6㎎ QD TS-143 Drug: TS-143 6mg Drug: Placebo
- Primary Outcome Measures
Name Time Method 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.
Serum erythropoietin (EPO) concentration 72 hours 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taisho Pharmaceutical Co., Ltd selected site
🇯🇵Tokyo, Japan