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

Sponsor

Taisho Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03591133

Collaborator

(none)

Enrollment

Location

Arms

3.7

Actual Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: TS-143 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Dec 24, 2015

Actual Primary Completion Date :

Apr 14, 2016

Actual Study Completion Date :

Apr 14, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Step1:3㎎ QD Drug: TS-143 3mg Drug: Placebo	Drug: TS-143 Drug: Placebo
Other: Step2:6㎎ QD Drug: TS-143 6mg Drug: Placebo	Drug: TS-143 Drug: Placebo
Other: Step3-1:11㎎ QD Drug: TS-143 11mg Drug: Placebo	Drug: TS-143 Drug: Placebo
Other: Step3-2:11㎎ QD（Fed) Drug: TS-143 11mg Drug: Placebo	Drug: TS-143 Drug: Placebo
Other: Step4:20㎎ QD Drug: TS-143 20mg Drug: Placebo	Drug: TS-143 Drug: Placebo
Other: Step5:36㎎ QD Drug: TS-143 36mg Drug: Placebo	Drug: TS-143 Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 39 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subjects with a body-mass index (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 prior to the investigational drug treatment

Exclusion Criteria:

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

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taisho Pharmaceutical Co., Ltd selected site	Tokyo		Japan

Sponsors and Collaborators

Taisho Pharmaceutical Co., Ltd.

Investigators

Study Director: Shigeru Okuyama, Taisho Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taisho Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03591133

Other Study ID Numbers:

TS143-01-01

First Posted:

Jul 19, 2018

Last Update Posted:

Dec 4, 2019

Last Verified:

Jul 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 4, 2019