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

• Sponsor: Taisho Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04979572
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 7.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult Subjects	Drug: TS-172; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official 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
• Actual Study Start Date: Aug 16, 2021
• Actual Primary Completion Date: Jan 26, 2022
• Actual Study Completion Date: Jan 26, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

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

Eligibility Criteria

Criteria

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

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

1. 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

1. Those who have a history of gastrointestinal ulceration

2. 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Taisho Pharmaceutical Co., Ltd.

Investigators

• Study Director: Taisho Director, Taisho Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taisho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04979572
• Other Study ID Numbers: TS172-101
• First Posted: Jul 28, 2021
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 12, 2022