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

NCT ID: NCT05871905

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-19
• Study Completion Date: 2024-06-20

Brief Summary

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

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TY-9591

TY-9591

Group Type: EXPERIMENTAL

TY-9591

Intervention Type: DRUG

C14 TY-9591

Interventions

TY-9591

C14 TY-9591

Intervention Type: DRUG

Other Intervention Names

C14 TY-9591

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

TYK Medicines, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mu Liyan

Role: PRINCIPAL_INVESTIGATOR

Suzhou First People's Hospital

Locations

Suzhou first people's hospital

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

TYKM1601103

Identifier Type: -

Identifier Source: org_study_id