Mass Balance Study of TS-142 in Healthy Adult Subjects.

• ClinicalTrials.gov Identifier: NCT04814771
• Recruitment Status: Completed
• First Posted: March 24, 2021
• Last Update Posted: June 11, 2021
• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Taisho Pharmaceutical Co., Ltd.

Study Description

Brief Summary:

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-142 after single oral dose of [14C] TS-142 in Japanese healthy male subjects.

To assess the safety of single oral dose of [14C] TS-142 in Japanese healthy male subjects.

Condition or disease	Intervention/treatment	Phase
Healthy Male Subjects	Drug: [14C] TS-142	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Mass Balance Recovery, Pharmacokinetics, Metabolite Identification and Profiling of 14C-labeled TS-142 in Healthy Adult Subjects.
• Actual Study Start Date: April 19, 2021
• Actual Primary Completion Date: May 19, 2021
• Actual Study Completion Date: May 19, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: [14C] TS-142; Participants will receive oral [14C] TS-142 under fasted conditions	Drug: [14C] TS-142; Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq [14C]TS-142 as an oral solution

Outcome Measures

Primary Outcome Measures :

1. Radioactivity concentration in whole blood and plasma [ Time Frame: Up to 168 hours after dosing ]
2. Calculation of cumulative urinary and fecal recovery of total radioactivity, and calculation of mass balance as a sum of the percentages of total radioactivity recovered in urine and faeces [ Time Frame: Up to 168 hours after dosing ]
3. Concentration of unchanged form and its major metabolites in plasma [ Time Frame: Up to 168 hours after dosing ]
4. Percentage of TS-142 and metabolites to total radioactivity in plasma [ Time Frame: Up to 168 hours after dosing ]
5. Percentage of TS-142 and metabolites to total radioactivity in urine and faeces [ Time Frame: Up to 168 hours after dosing ]
6. Metabolite profiling and structural identification of metabolites in plasma, urine and faeces [ Time Frame: Up to 168 hours after dosing ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Japanese males aged >=20 and <40 years at the signing of informed consent
• Subjects whose body mass index (BMI) >=18.5 and <25.0 kg/m2 at screening
• Subjects who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test and the test on the day of admission and the test obtained prior to administration of the investigational drug, and whose clinical test results are within the standard values of the clinical trial site in the screening test and the test on the day of admission. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator(s) or subinvestigator(s).
• Subjects who understand, and have willingness and ability to read and sign, the informed consent form

Exclusion Criteria:

• Subjects who have received a substance labeled with a radioisotope within the last 12 months prior to dosing of the investigational drug
• Subjects who have been exposed to a large amount of radiation for therapeutic or diagnostic reasons (CT scan, stomach X-ray, PET scan etc.) within the last 12 months prior to dosing of the investigational drug
• Occupationally exposed worker in the last 12 months prior to dosing of the investigational drug
• Subjects who have had 3 days or less that one or more spontaneous defecations (defecation that occurs without laxatives, enemas, disimpaction) within 7 days before consent is obtained and during the 7 days until on the day of admission. Those who have diarrhea during the 7 days until on the day of admission
• History of any disease or surgery which have impact on investigational drug absorption such as gastrectomy, gastroenterostomy or bowel resection
• Other protocol defined exclusion criteria could apply

Contacts and Locations

Locations

Japan

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Sponsors and Collaborators

Taisho Pharmaceutical Co., Ltd.

Investigators

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

More Information

• Responsible Party: Taisho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04814771
• Other Study ID Numbers: TS142-206
• First Posted: March 24, 2021
• Last Update Posted: June 11, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No