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Completed

NCT Number: NCT04979572

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

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Key information

Age range

20 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Toshima-ku, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 2 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

Treatment and study plan

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

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

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)

    Time frame: 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

  1. Concentration of unchanged form in plasma, urine and stool

    Time frame: Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11

  2. Area under the plasma concentration-time curve (AUC) of unchanged form

    Time frame: Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11

  3. Mean daily urinaly excretion of sodium and phosphorus

    Time frame: 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

  4. Mean daily Bristol Stool Form Scale (BSFS)

    Time frame: 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

    BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2021
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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