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CompletedNCT06255951Updated Dec 30, 2024

Studies Evaluating the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of TY-9591 Tablets in Healthy Subjects

A Phase 1 interventional study of Itraconazole and Rifampicin in NSCLC, sponsored by TYK Medicines, Inc. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-12-30.

Sponsored by TYK Medicines, Inc · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • NSCLC
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In context

Lead sponsor

TYK Medicines, Inc is the lead sponsor of 17 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. Body mass index (BMI) between 19.0 and 26.0 kg/m2 [BMI= weight (kg)/ height 2 (m2)] (including boundary values).
  3. 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.
  4. Subjects voluntarily participated and signed an informed consent form.
  5. Subjects had good communication with investigators and were able to complete the trial in accordance with the protocol.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. 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).
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. taking any medicine (including Chinese herbal medicine and health supplements) within 14 days before taking the test drug.
  9. enrollment in any drug clinical trial within 3 months before the screening period.
  10. Subjects who may not be able to complete the study for other reasons or who are considered unsuitable for the study by the investigators.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Itraconazole

    Itraconazole

    Drug: Itraconazole

  • Experimental
    Rifampicin

    Rifampicin

    Drug: Rifampicin

Interventions

  • DrugItraconazole

    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.

  • DrugRifampicin

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: through study completion,an average of 6 months

  2. 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)

    Time frame: through study completion,an average of 6 months

  3. 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

    Time frame: through study completion,an average of 6 months

Secondary outcomes

  1. 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

    Time frame: through study completion,an average of 6 months

  2. 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

    Time frame: through study completion,an average of 6 months

  3. 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

    Time frame: through study completion,an average of 6 months

  4. 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

    Time frame: through study completion,an average of 6 months

  5. 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

    Time frame: through study completion,an average of 6 months

  6. 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

    Time frame: through study completion,an average of 6 months

  7. Cmax ratio of metabolites to original drug

    Cmax ratio of metabolites to original drug

    Time frame: through study completion,an average of 6 months

  8. AUC ratio of metabolites to original drug

    AUC ratio of metabolites to original drug

    Time frame: through study completion,an average of 6 months

07

Study locations

1 site
  • Yali Liu
    Guangdong, Shantou 515041, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06255951
Lead sponsor
TYK Medicines, Inc
Responsible party
Sponsor
First posted
Feb 13, 2024
Start date
Mar 12, 2024
Primary completion
May 23, 2024
Completion
Dec 27, 2024
Last update
Dec 30, 2024

Study contacts

yali liu
principal investigator · Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Itraconazole · Rifampin

Other studies from this sponsor

TYK Medicines, Inc

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