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

Healthy Participants Clinical Trial

Official title:

Phase I Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591133
• Other study ID #: TS143-01-01
• Status: Completed
• Phase: Phase 1
• Start date: December 24, 2015
• Est. completion date: April 14, 2016

Study information

• Verified date: June 2023
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 14, 2016
• Est. primary completion date: April 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• TS-143

• Placebo

Locations

Country	Name	City	State
Japan	Taisho Pharmaceutical Co., Ltd selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Shinfuku A, Shimazaki T, Fujiwara M, Sato F, Watase H, Numazaki T, Kawakita Y, Mutoh M, Yamasaki H, Takayama N, Kato S, Sugimoto T, Maruyama J. Novel Compound Induces Erythropoietin Secretion through Liver Effects in Chronic Kidney Disease Patients and He — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	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.	8 days
Primary	Plasma concentrations of unchanged form (ng/mL)	The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing.	72 hours
Primary	Urinary excretions of unchanged form (ng/mL)	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.	72 hours
Primary	Serum erythropoietin (EPO) concentration		72 hours