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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871905
• Other study ID #: TYKM1601103
• Status: Recruiting
• Phase: Phase 1
• Start date: June 25, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: TYK Medicines, Inc
• Contact: Mu Liyan
• Phone: 18915505252
• Email: miaolysuzhou[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 1, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TY-9591
C14 TY-9591

Locations

Country	Name	City	State
China	Suzhou first people's hospital	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
TYK Medicines, Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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