[14 C] Study on Mass Balance of TY-9591 in Healthy Chinese Subjects

[14 C] Study on Mass Balance of TY-9591 in Healthy Chinese Adult Male Subjects

[14 C] Mass balance clinical trial of TY-9591 in healthy Chinese subjects

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: TY-9591

Detailed Description

This is a single-center, non-randomized, one-arm, open trial in healthy adult subjects. The study population is male healthy subjects. The trial consisted of a screening period, a trial period and a follow-up period. A total of 6-10 healthy Chinese adult male subjects were planned to be enrolled and divided into groups according to specific conditions.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Suzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. Be at least 50.0 kg in weight, and have a body mass index (BMI) in the range of 18.0-30.0 [BM= weight (kg)/ height 2(m)] (including the critical value.

  2.Subjects were sterile themselves, or voluntarily took highly effective non-drug contraception or abstained from sex completely from the beginning of self-medication to 1 year after administration.

  3.Volunteer to participate and sign informed consent, be able to communicate well with the investigator and complete the investigator in accordance with the study regulations.

Exclusion Criteria:

• 1.After a thorough physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, coagulation function). Urine routine, stool routine + occult blood), anal digital examination, thyroid function, 12-lead electrocardiogram, chest X-ray (positive position), abdominal color Doppler ultrasound, liver, bile, pancreas, spleen and kidney) and other tests with clinical significance.

  2.Abnormal ophthalmic examination (intraocular pressure, slit lamp, fundus film) with clinical significance.

  3.Test positive for either hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antigen/antibody, or syphilis antibo.

  4.Those who smoked more than 5 cigarettes a day or habitually used nicotine products in the 3 months before screening, or were unable to abstain during the trial.

  5.A history of severe diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism and bone system, or any other disease or physiological condition that may affect the results of the study.

  6.Who participated in any drug clinical trial as a subject within 3 months prior to the administration of this trial.

  7.Those who had taken any prescription, over-the-counter, herbal and health products in the 14 days prior to screening.

  8.Those who cannot tolerate venous puncture blood collection or fainting blood or fainting needle.

  9.Those who have special dietary requirements and fail to follow the diets and regulations provided.

  10.The investigator considers it inappropriate to participate in clinical trials or is otherwise unable to complete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TY-9591	Drug: TY-9591; C14 TY-9591; Other Names: C14 TY-9591

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total radioactivity in whole blood and plasma after a single oral administration of 14C TY-9591	The total radioactivity in excreta after oral administration of 14C TY-9591	After oral administration of 14C TY-9591, the radiometabolite profiles of plasma, urine and stool were obtained to identify the major metabolites

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The concentrations of TY-9591 by the verified LC-MS/MS method to obtain the pharmacokinetic parameters of TY-9591 and its metabolites D1 and D2 or ot	To observe the safety of 14C TY-9591 in healthy subjects after a single dose	8m

Collaborators and Investigators

• Sponsor: TYK Medicines, Inc
• Investigators: Principal Investigator: Mu Liyan, Suzhou First People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): November 6, 2023
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TYKM1601103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No