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

Healthy Adult Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04979572
• Other study ID #: TS172-101
• Status: Completed
• Phase: Phase 1
• Start date: August 16, 2021
• Est. completion date: January 26, 2022

Study information

• Verified date: April 2022
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 26, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

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
• 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

Locations

Country	Name	City	State
Japan	Taisho Pharmaceutical Co., Ltd selected site	Toshima-ku

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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