Clinical Study of TS-143 in Healthy Adult Male Subjects (Multiple-Dose Administration)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Step1:4㎎ TID TS-143 12mg total dose/day or Placebo |
Drug: TS-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.
Drug: Placebo
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.
|
| Other: Step2:11㎎ TID TS-143 33mg total dose/day or Placebo |
Drug: TS-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.
Drug: Placebo
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.
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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:
- 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
- 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
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taisho Pharmaceutical Co., Ltd selected site | Tokyo | Japan |
Sponsors and Collaborators
- Taisho Pharmaceutical Co., Ltd.
Investigators
- Study Director: Shigeru Okuyama, Taisho Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TS143-01-03