A Mass Balance Study of TS-172 in Healthy Adult Subjects | NCT06596356

Studies
A Mass Balance Study of TS-172 in Healthy Adult Subjects

NCT06596356

Sponsor

Taisho Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Feb 28, 2025Actual

Enrollment

6Actual

Phase

Phase 1

Conditions

Healthy Male Subjects

Interventions

[14C] TS-172

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2024Actual

Primary Completion Date

Oct 28, 2024Actual

Completion Date

Oct 28, 2024Actual

First Submitted Date

Sep 2, 2024

First Submission Date that Met QC Criteria

Sep 10, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2025

Last Update Posted Date

Feb 28, 2025Actual

Description Module

Brief Summary

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-172 after single oral dose of [14C] TS-172 in Japanese healthy male subjects.

To assess the safety of single oral dose of [14C] TS-172 in Japanese healthy male subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
[14C] TS-172	Experimental	Participants will receive oral [14C] TS-172 under fasted conditions	Drug: [14C] TS-172

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[14C] TS-172	Drug	Subjects will receive single dose of about 30 mg of TS-172 containing 1 MBq [14C]TS-172 as an oral solution	[14C] TS-172

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radioactivity concentration in whole blood and plasma		Up to 240 hours after dosing
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		Up to 240 hours after dosing
Concentration of unchanged form and its major metabolites in plasma		Up to 240 hours after dosing
Percentage of unchanged form and metabolites to total radioactivity in plasma		Up to 240 hours after dosing
Percentage of unchanged form and metabolites to total radioactivity in urine and faeces		Up to 240 hours after dosing

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 or values outside the reference ranges 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 been administered substances labelled with radioisotopes or exposed to high levels of radiation (e.g. CT scan, gastric X-ray, PET scan) within one year prior to dosing of the investigational drug.
Occupationally exposed worker within one year prior to dosing of the investigational drug (e.g. workers who handle nuclear power or radioactive substances)
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 or 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 gastrointestinal ulcer, gastrectomy, gastroenterostomy or bowel resection

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided