A Phase I Study of TS-172 in Healthy Adult Subjects (Single and Multiple Doses)

A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects

A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects

Study Overview

• Status: Completed
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Drug: TS-172; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Toshima-ku, Japan
    • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Japanese healthy males aged 20 years or older but less than 40 years at the time of informed consent
2. Those with a BMI of 18.5 or more and less than 25.0 at screening test
3. Those who are able to receive the explanation before participating in the study, understand the content of the study, and provide written informed consent by the subjects themselves.

Exclusion Criteria:

1. Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.

2. Those who correspond to any of the following about bowel movements;

   • Repeated diarrhea (Bristol Stool Form Score [BSFS] score of 6 or higher) on a daily basis
   • Repeated constipation (no defecation for 2 days or more in a week) on a daily basis

3. Those who correspond to any of the following about bowel movements in the 7 days before administration;

   • Diarrhea on 2 or more days in 7 days
   • 2 or more days without a bowel movement in 7 days
4. Those who have a history of gastrointestinal ulceration

5. Those who correspond to any of the following about infection;

   • Positive for SARS-CoV-2 in the nucleic acid amplification test performed at the time of admission
   • Suspected of having COVID-19

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg; Single dose of TS-172 or placebo before breakfast	Drug: TS-172; Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting); Multiple dose of TS-172 90 mg before breakfast and dinner; Drug: Placebo; Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2); Multiple dose of TS-172 placebo before breakfast and dinner
Experimental: Part B (multiple dose) : Step 5: TS-172 90 mg; Multiple dose of TS-172 or placebo before breakfast and dinner	Drug: TS-172; Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting); Multiple dose of TS-172 90 mg before breakfast and dinner; Drug: Placebo; Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2); Multiple dose of TS-172 placebo before breakfast and dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)	Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of unchanged form in plasma, urine and stool		Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11
Area under the plasma concentration-time curve (AUC) of unchanged form		Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11
Mean daily urinaly excretion of sodium and phosphorus		Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11
Mean daily Bristol Stool Form Scale (BSFS)	BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool	Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): January 26, 2022
• Study Completion (Actual): January 26, 2022

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TS172-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No