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

• ClinicalTrials.gov Identifier: NCT03591133
• Recruitment Status: Completed
• First Posted: July 19, 2018
• Last Update Posted: December 4, 2019
• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Taisho Pharmaceutical Co., Ltd.

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 (Clinical Trial)
• 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: December 24, 2015
• Actual Primary Completion Date: April 14, 2016
• Actual Study Completion Date: April 14, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 39 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Japan

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Sponsors and Collaborators

Taisho Pharmaceutical Co., Ltd.

Investigators

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

More Information

Publications of Results:

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 Healthy Volunteers. Am J Nephrol. 2018;48(3):157-164. doi: 10.1159/000492181. Epub 2018 Sep 3.

• Responsible Party: Taisho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03591133
• Other Study ID Numbers: TS143-01-01
• First Posted: July 19, 2018
• Last Update Posted: December 4, 2019
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No