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

NCT05871905 | Completed Phase 1

• 1 other identifier: TYKM1601103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

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Study Arms (1)

TY-9591

EXPERIMENTAL

TY-9591

Drug: TY-9591

Interventions

TY-9591 DRUG

C14 TY-9591

Also known as: C14 TY-9591

TY-9591

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• 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.
• 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.

You may not qualify if:

• 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.
• Abnormal ophthalmic examination (intraocular pressure, slit lamp, fundus film) with clinical significance.
• Test positive for either hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antigen/antibody, or syphilis antibo.
• 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.
• 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.
• Who participated in any drug clinical trial as a subject within 3 months prior to the administration of this trial.
• Those who had taken any prescription, over-the-counter, herbal and health products in the 14 days prior to screening.
• Those who cannot tolerate venous puncture blood collection or fainting blood or fainting needle.
• Those who have special dietary requirements and fail to follow the diets and regulations provided.
• The investigator considers it inappropriate to participate in clinical trials or is otherwise unable to complete the study.

Sponsors & Collaborators

• TYK Medicines, Inc: lead

Study Sites (1)

Suzhou first people's hospital

Suzhou, Jiangsu, China

Location

Study Officials

• Mu Liyan

  Suzhou First People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 23, 2023
• Study Start: June 19, 2023
• Primary Completion: November 6, 2023
• Study Completion: June 20, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)