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

NCT04979572 | Completed Phase 1

• 1 other identifier: TS172-101
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

  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

Study Arms (2)

Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg

EXPERIMENTAL

Single dose of TS-172 or placebo before breakfast

Drug: TS-172; Drug: Placebo

Part B (multiple dose) : Step 5: TS-172 90 mg

EXPERIMENTAL

Multiple dose of TS-172 or placebo before breakfast and dinner

Drug: TS-172; Drug: Placebo

Interventions

TS-172 DRUG

* 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

Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg; Part B (multiple dose) : Step 5: TS-172 90 mg

Placebo DRUG

* 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

Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg; Part B (multiple dose) : Step 5: TS-172 90 mg

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese healthy males aged 20 years or older but less than 40 years at the time of informed consent
• Those with a BMI of 18.5 or more and less than 25.0 at screening test
• 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.

You may not qualify if:

• Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.
• 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
• 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
• or more days without a bowel movement in 7 days
• Those who have a history of gastrointestinal ulceration
• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Toshima-ku, Japan

Location

Study Officials

• Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 28, 2021
• Study Start: August 16, 2021
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: February 28, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)