NSCLCPhase 1NCT06255951
Studies Evaluating the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of TY-9591 Tablets in Healthy Subjects
A Phase 1 study testing Itraconazole and Rifampicin in people with NSCLC, run by TYK Medicines, Inc at 1 site in China.
Trial summary
Studies evaluating the effects of itraconazole or rifampicin on the pharmacokinetics of TY-9591 tablets in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Itraconazole and Rifampicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2024to 27 Dec 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female healthy adult subjects aged 18-45 years old (inclusive), in which male or female accounted for no less than 1/4 of the total number of subjects in each sequence.
- Body mass index (BMI) between 19.0 and 26.0 kg/m2 [BMI= weight (kg)/ height 2 (m2)] (including boundary values).
- Participants (including male participants) were infertile themselves, or agreed to use highly effective nonpharmacologic contraceptive methods or abstain completely from sex for 6 months after the last dose of self-medication.
- Subjects voluntarily participated and signed an informed consent form.
- Subjects had good communication with investigators and were able to complete the trial in accordance with the protocol.
Who cannot join
- Those with clinically significant abnormalities in physical examination, vital signs, routine laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram, ophthalmic examination, abdominal color Doppler ultrasound (liver, bile duct, pancreas, spleen, kidney), etc.
- Persons with one or more positive results of human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, or treponema pallidum antibody (Anti-TP).
- smokers with an average of more than 10 cigarettes per day in the previous 3 months or habitual users of nicotine products who could not quit during the study.
- Heavy drinking or regular drinking in the 3 months before the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Or alcohol breath test results on admission \> 0.0 mg/100 mL and those who could not abstain from alcohol during the experiment.
- those who consumed excessive amounts of tea, coffee, and/or caffeinated beverages (average > 8 cups/day, 250 mL/cup) in the 3 months before the screening period, and those who could not stop using them during the study period.
- those who took dragon fruit, mango, grapefruit, chocolate, any food or beverage containing caffeine, diet rich in xanthine, and other special diets affecting drug absorption, distribution, metabolism, and excretion within 7 days before taking the drug.
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- Use of any drugs that inhibit or induce the liver CYP3A4 enzyme (see Appendix II), herbs, or foods containing herbal ingredients within 30 days before the screening period.
- taking any medicine (including Chinese herbal medicine and health supplements) within 14 days before taking the test drug.
- enrollment in any drug clinical trial within 3 months before the screening period.
- Subjects who may not be able to complete the study for other reasons or who are considered unsuitable for the study by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: This is a Single-center, Two-sequence, Open-label, Two-cycle Drug-drug Interaction (DDI) Study in Healthy Subjects. To Evaluate the Effects of Itraconazole Capsules, a Strong Inhibitor of CYP3A4, and Rifampicin Capsules, a Strong Inducer, on the Pharmacokinetics of TY-9591 Tablets After a Single Oral Dose
Studies evaluating the effects of itraconazole or rifampicin on the pharmacokinetics of TY-9591 tablets in healthy subjects
Read the detailed description
To evaluate the pharmacokinetics of TY-9591 tablets in healthy Chinese subjects after a single oral administration. To evaluate the effects of itraconazole/rifampicin on the pharmacokinetics of TY-9591 and its metabolites D1 and D2 after oral administration of TY-9591 tablets.
- Conditions
- NSCLC
- Being tested
- Itraconazole, Rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
The study was divided into two sequences with a planned enrollment of 48 healthy adult subjects (24 in each sequence). PartA was the itraconazole study sequence, which was used to study the effect of itraconazole on the pharmacokinetic characteristics of TY-9591 tablets after multiple doses.
RifampicinDrug
The study was divided into two sequences with a planned enrollment of 48 healthy adult subjects (24 in each sequence). PartB was the rifampin study sequence, which investigated the effect of multiple doses of rifampin on the pharmacokinetic profile of TY-9591 tablets.
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole | Experimental | Itraconazole Receives: Drug: Itraconazole |
| Rifampicin | Experimental | Rifampicin Receives: Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentrations (Cmax) of TY-9591 and its metabolites D1 and D2
Peak plasma concentrations (Cmax) of TY-9591 and its metabolites D1 and D2
Measured: through study completion,an average of 6 months
Area under the concentration-time curve from 0 to the last quantifiable time point after dose administration (AUC0-t)
Area under the concentration-time curve from 0 to the last quantifiable time point after dose administration (AUC0-t)
Measured: through study completion,an average of 6 months
Area under the concentration-time curve from 0 to infinity (AUC0-inf), as data permit
Area under the concentration-time curve from 0 to infinity (AUC0-inf), as data permit
Measured: through study completion,an average of 6 months
Secondary outcomes (8)
Time to peak concentration (Tmax) of TY-9591 and its metabolites D1 and D2
Time to peak concentration (Tmax) of TY-9591 and its metabolites D1 and D2
Measured: through study completion,an average of 6 months
The half-life of elimination phase (t1/2) of TY-9591 and its metabolites D1 and D2
The half-life of elimination phase (t1/2) of TY-9591 and its metabolites D1 and D2
Measured: through study completion,an average of 6 months
elimination rate constant (λz) of TY-9591 and its metabolites D1 and D2
elimination rate constant (λz) of TY-9591 and its metabolites D1 and D2
Measured: through study completion,an average of 6 months
apparent clearance rate (CL/F) of TY-9591 and its metabolites D1 and D2
apparent clearance rate (CL/F) of TY-9591 and its metabolites D1 and D2
Measured: through study completion,an average of 6 months
apparent volume of distribution (Vd/F) of TY-9591 and its metabolites D1 and D2
apparent volume of distribution (Vd/F) of TY-9591 and its metabolites D1 and D2
Measured: through study completion,an average of 6 months
mean retention time (MRT) of TY-9591 and its metabolites D1 and D2
mean retention time (MRT) of TY-9591 and its metabolites D1 and D2
Measured: through study completion,an average of 6 months
Cmax ratio of metabolites to original drug
Cmax ratio of metabolites to original drug
Measured: through study completion,an average of 6 months
AUC ratio of metabolites to original drug
AUC ratio of metabolites to original drug
Measured: through study completion,an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start12 Mar 2024
- Primary completion23 May 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- PartA is the itraconazole study sequence,PartB was the rifampin study sequence.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- TYK Medicines, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yali liu, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255951
- Sponsor's protocol ID
- TYKM1601105
- Status last verified
- Dec 2024
- First submitted
- 17 Jan 2024
- 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
- This is a Single-center, Two-sequence, Open-label, Two-cycle Drug-drug Interaction (DDI) Study in Healthy Subjects. To Evaluate the Effects of Itraconazole Capsules, a Strong Inhibitor of CYP3A4, and Rifampicin Capsules, a Strong Inducer, on the Pharmacokinetics of TY-9591 Tablets After a Single Oral Dose
- ClinicalTrials.gov ID
- NCT06255951
- Acronym / sponsor ID
- TYKM1601105
- Conditions
- NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- TYK Medicines, IncIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 13 Feb 2024 (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.
Studies evaluating the effects of itraconazole or rifampicin on the pharmacokinetics of TY-9591 tablets in healthy subjects
Detailed description
To evaluate the pharmacokinetics of TY-9591 tablets in healthy Chinese subjects after a single oral administration. To evaluate the effects of itraconazole/rifampicin on the pharmacokinetics of TY-9591 and its metabolites D1 and D2 after oral administration of TY-9591 tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PartA is the itraconazole study sequence,PartB was the rifampin study sequence.
| Arm | Type | Receives |
|---|---|---|
| Itraconazole | Experimental | Drug: ItraconazoleItraconazole |
| Rifampicin | Experimental | Drug: RifampicinRifampicin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female healthy adult subjects aged 18-45 years old (inclusive), in which male or female accounted for no less than 1/4 of the total number of subjects in each sequence.
- Body mass index (BMI) between 19.0 and 26.0 kg/m2 [BMI= weight (kg)/ height 2 (m2)] (including boundary values).
- Participants (including male participants) were infertile themselves, or agreed to use highly effective nonpharmacologic contraceptive methods or abstain completely from sex for 6 months after the last dose of self-medication.
- Subjects voluntarily participated and signed an informed consent form.
- Subjects had good communication with investigators and were able to complete the trial in accordance with the protocol.
Key exclusion criteria (10 listed)
- Those with clinically significant abnormalities in physical examination, vital signs, routine laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram, ophthalmic examination, abdominal color Doppler ultrasound (liver, bile duct, pancreas, spleen, kidney), etc.
- Persons with one or more positive results of human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, or treponema pallidum antibody (Anti-TP).
- smokers with an average of more than 10 cigarettes per day in the previous 3 months or habitual users of nicotine products who could not quit during the study.
- Heavy drinking or regular drinking in the 3 months before the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Or alcohol breath test results on admission \> 0.0 mg/100 mL and those who could not abstain from alcohol during the experiment.
- those who consumed excessive amounts of tea, coffee, and/or caffeinated beverages (average > 8 cups/day, 250 mL/cup) in the 3 months before the screening period, and those who could not stop using them during the study period.
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 |
|---|---|---|
| ItraconazoleThe study was divided into two sequences with a planned enrollment of 48 healthy adult subjects (24 in each sequence). PartA was the itraconazole study sequence, which was used to study the effect of itraconazole on the pharmacokinetic characteristics of TY-9591 tablets after multiple doses. | Drug | Itraconazole |
| RifampicinThe study was divided into two sequences with a planned enrollment of 48 healthy adult subjects (24 in each sequence). PartB was the rifampin study sequence, which investigated the effect of multiple doses of rifampin on the pharmacokinetic profile of TY-9591 tablets. | Drug | Rifampicin |
Primary outcome
Peak plasma concentrations (Cmax) of TY-9591 and its metabolites D1 and D2
Time frame: through study completion,an average of 6 months
Peak plasma concentrations (Cmax) of TY-9591 and its metabolites D1 and D2
Area under the concentration-time curve from 0 to the last quantifiable time point after dose administration (AUC0-t)
Time frame: through study completion,an average of 6 months
Area under the concentration-time curve from 0 to the last quantifiable time point after dose administration (AUC0-t)
Area under the concentration-time curve from 0 to infinity (AUC0-inf), as data permit
Time frame: through study completion,an average of 6 months
Area under the concentration-time curve from 0 to infinity (AUC0-inf), as data permit
8 secondary outcomes
Time to peak concentration (Tmax) of TY-9591 and its metabolites D1 and D2
Time frame: through study completion,an average of 6 months
The half-life of elimination phase (t1/2) of TY-9591 and its metabolites D1 and D2
Time frame: through study completion,an average of 6 months
elimination rate constant (λz) of TY-9591 and its metabolites D1 and D2
Time frame: through study completion,an average of 6 months
apparent clearance rate (CL/F) of TY-9591 and its metabolites D1 and D2
Time frame: through study completion,an average of 6 months
apparent volume of distribution (Vd/F) of TY-9591 and its metabolites D1 and D2
Time frame: through study completion,an average of 6 months
mean retention time (MRT) of TY-9591 and its metabolites D1 and D2
Time frame: through study completion,an average of 6 months
Cmax ratio of metabolites to original drug
Time frame: through study completion,an average of 6 months
AUC ratio of metabolites to original drug
Time frame: through study completion,an average of 6 months
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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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.
yali liu principal investigator
Investigator
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 Itraconazole and Rifampicin in people with NSCLC, 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 5 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?
Peak plasma concentrations (Cmax) of TY-9591 and its metabolites D1 and D2 (time frame: through study completion,an average of 6 months). The study lists 3 primary outcomes in all. 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; AzTrials last refreshed its copy on 8 Nov 2026.