Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-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

NCT03591133

TS143-01-01

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 6 patient groups

Step1:3㎎ QD

Other group

Description:

Drug: TS-143 3mg Drug: Placebo

Treatment:

Drug: Placebo

Drug: TS-143

Step2:6㎎ QD

Other group

Description:

Drug: TS-143 6mg Drug: Placebo

Treatment:

Drug: Placebo

Drug: TS-143

Step3-1:11㎎ QD

Other group

Description:

Drug: TS-143 11mg Drug: Placebo

Treatment:

Drug: Placebo

Drug: TS-143

Step3-2:11㎎ QD（Fed)

Other group

Description:

Drug: TS-143 11mg Drug: Placebo

Treatment:

Drug: Placebo

Drug: TS-143

Step4:20㎎ QD

Other group

Description:

Drug: TS-143 20mg Drug: Placebo

Treatment:

Drug: Placebo

Drug: TS-143

Step5:36㎎ QD

Other group

Description:

Drug: TS-143 36mg Drug: Placebo

Treatment:

Drug: Placebo

Drug: TS-143