Clinical Study of TS-143 in Healthy Adult Male Subjects (Multiple-Dose Administration)

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: TS-143; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03595202

TS143-01-03

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

Step1:4㎎ TID

Other group

Description:

TS-143 12mg total dose/day or Placebo

Treatment:

Drug: Placebo

Drug: TS-143

Step2:11㎎ TID

Other group

Description:

TS-143 33mg total dose/day or Placebo

Treatment:

Drug: Placebo

Drug: TS-143