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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595202
• Other study ID #: TS143-01-03
• Status: Completed
• Phase: Phase 1
• Start date: April 3, 2017
• Est. completion date: July 7, 2017

Study information

• Verified date: July 2018
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 7, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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.
• 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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of subjects with adverse events	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.	18 days
Primary	Plasma concentrations of unchanged form (ng/mL)		13 days
Primary	Urinary excretions of unchanged form (ng/mL)		12 days
Primary	Serum EPO concentration		13 days
Primary	Reticulocyte count		13 days
Primary	Plasma vascular endothelial growth factor (VEGF) concentration		13 days
Primary	Serum iron (µg/dL)		13 days
Primary	Total iron binding capacity(µg/dL)		13 days