Healthy VolunteersPhase 1NCT05871905
[14 C] Study on Mass Balance of TY-9591 in Healthy Chinese Subjects
A Phase 1 study testing TY-9591 in people with Healthy Volunteers, run by TYK Medicines, Inc at 1 site in China.
Trial summary
[14 C] Mass balance clinical trial of TY-9591 in healthy Chinese subjects Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TY-9591
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2023to 20 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: [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
Read the 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
- Being tested
- TY-9591
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TY-9591Drug
Also called C14 TY-9591
C14 TY-9591
| Study group | Role | What they receive |
|---|---|---|
| TY-9591 | Experimental | TY-9591 Receives: Drug: TY-9591 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
To observe the safety of 14C TY-9591 in healthy subjects after a single dose
Measured: 8m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start19 Jun 2023
- Primary completion6 Nov 2023
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- TYK Medicines, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mu Liyan, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871905
- Sponsor's protocol ID
- TYKM1601103
- Status last verified
- Dec 2024
- First submitted
- 15 May 2023
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [14 C] Study on Mass Balance of TY-9591 in Healthy Chinese Adult Male Subjects
- ClinicalTrials.gov ID
- NCT05871905
- Acronym / sponsor ID
- TYKM1601103
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- TYK Medicines, IncIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
[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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TY-9591 | Experimental | Drug: TY-9591TY-9591 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TY-9591Also: C14 TY-9591C14 TY-9591 | Drug | TY-9591 |
Primary outcome
The total radioactivity in whole blood and plasma after a single oral administration of 14C TY-9591
Time frame: After oral administration of 14C TY-9591, the radiometabolite profiles of plasma, urine and stool were obtained to identify the major metabolites
The total radioactivity in excreta after oral administration of 14C TY-9591
1 secondary outcome
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
Time frame: 8m
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mu Liyan principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TY-9591 in people with Healthy Volunteers, run by TYK Medicines, Inc at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total radioactivity in whole blood and plasma after a single oral administration of 14C TY-9591 (time frame: After oral administration of 14C TY-9591, the radiometabolite profiles of plasma, urine and stool were obtained to identify the major metabolites). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.