Phase I Clinical Study of TS-143 in Healthy Adult Male Subjects (Multiple-Dose Administration)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Plasma vascular endothelial growth factor (VEGF) concentration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 39 Years (Adult)
- Sex
- Male
- Accepts 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
- •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
Arms & Interventions
Step1:4㎎ TID
TS-143 12mg total dose/day or Placebo
Intervention: TS-143 (Drug)
Step1:4㎎ TID
TS-143 12mg total dose/day or Placebo
Intervention: Placebo (Drug)
Step2:11㎎ TID
TS-143 33mg total dose/day or Placebo
Intervention: TS-143 (Drug)
Step2:11㎎ TID
TS-143 33mg total dose/day or Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Plasma vascular endothelial growth factor (VEGF) concentration
Time Frame: 13 days
Plasma concentrations of unchanged form (ng/mL)
Time Frame: 13 days
Reticulocyte count
Time Frame: 13 days
Serum iron (μg／dL)
Time Frame: 13 days
Incidence of subjects with adverse events
Time Frame: 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.
Urinary excretions of unchanged form (ng/mL)
Time Frame: 12 days
Serum EPO concentration
Time Frame: 13 days
Total iron binding capacity（μg／dL）
Time Frame: 13 days
Secondary Outcomes
No secondary outcomes reported