Healthy VolunteersPhase 1NCT04798638

A Study to Assess the Effect of Food on the Pharmacokinetics of TY-9591 in Healthy Volunteers

A Phase 1 study testing TY-9591 Tablets under Fasted Condition - Arm1, Osimertinib Mesylate Tablets under Fasted Condition - Arm1 and TY-9591 Tablets after a High-fat Meal - Arm1 in people with Healthy Volunteers, run by TYK Medicines, Inc at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To assess the pharmacokinetics of TY-9591 tablets and Osimertinib Mesylate tablets after a single fasting administration and the effect of food on the pharmacokinetics of TY-9591 tablets in healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: TY-9591 Tablets under Fasted Condition - Arm1, Osimertinib Mesylate Tablets under Fasted Condition - Arm1 and TY-9591 Tablets after a High-fat Meal - Arm1
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteChina
Study dates: 30 Apr 2021to 9 Sep 2021
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male must be ≥ 18 and ≤ 55 years of age.
Bodyweight of male must be ≥ 50.0 kg (bodyweight of female must be ≥ 45.0 kg), and the Body Mass Index must be ≥ 19.0 and ≤26.0 kg/m2.
The participants must have no birthing plan and agree to take adequate non-drug contraceptive measures within 2 weeks before screening to 6 months after the last drug treatment.
The participants have good communications with investigators, understand and comply with all requirements and fully understand and sign the informed consent form.
The results of physical examination, vital signs, ECG, laboratory examination and other relevant examination should compliance with the clinical protocol, or they will be recognized as non-clinical signs (NCS) if beyond the regulated range.

Who cannot join

The participants who smoked daily >5 sticks of cigarette 3 months prior to screening or cannot give up smoking during study.
The participants consumed more than 14 units of alcohol per week (1 unit = 360 ml beers/45 ml liquor containing 40% alcohol/150 ml grape wine) 3 months prior to screening period, positive results of alcohol breath test and the volunteers who cannot give up drinking during study.
The participants who have overconsumption of tea, coffee, and the drink with caffeine (> 8 cup one day, 1 cup=250 ml) daily 3 months prior to screening period.
The participants have history of substance abuse and drug use within 6 months before screening.
The participants have history of chronic disease and serious illness in nervous system, vascular system, blood and lymphatic system, immune system, urinary system, respiratory system, digestive system and other metabolic system, any conditions and illness threat to the health of participants, and the history of hereditary disease.
The participants had a clinically significant disease, major surgery within 3 months before screening or plan surgery during the study period, and the surgery could affect drug absorption, distribution, metabolism, and excretion.

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The participants who participated other clinical trials and took the investigational drug 3 months prior to first dose.
The participants who have blood donation or excessive bleeding (≥ 400 ml) 3 months prior to first dose, and planned to donate blood or receive blood transfusions.
The participants who were taking any prescription medicine, any over-the-counter (OTC), traditional chinese medicine and health care products within 14 days prior to screening period; CYP3A4 inducers/inhibitors within 30 days prior to screening period.
The participants who have eaten grapefruit, orange, mango, pitaya, chocolate, any caffeinated food or drink that affects the absorption, distribution, metabolism and excretion of the drug within 7 days before first dose.
The participants who cannot comply with the roles of unified diet.
The participants who have positive test result in HBsAg, antibodies against HCV (anti-HCV), Anti-HCV, Anti-HIV and TPPA.
The participants who cannot tolerate blood collection through venipuncture.
Any factors judged by investigator that the participants cannot meet.

Trial locations and contacts

1 site in 1 country.

China1 site

Hunan Provincial Tumor Hospital
Changsha, Hunan, 410006

Other trials in China

About this study

Official title: Studies to Compare the Pharmacokinetics of TY-9591 Tablets and Osimertinib Mesylate Tablets After a Single Fasting Administration and Determine the Effect of Food on the Pharmacokinetics of TY-9591 Tablets in Healthy Volunteers

Read the detailed description

This is a single center, randomized, open label, two phases study in healthy adult volunteers. The first phase is a two-sequence, two-period crossover trial. The volunteers will be randomly distributed into two groups and given either TY-9591 tablets or Osimertinib Mesylate tablets on a single fasting administration. In the second phase, all volunteers will be administrated TY-9591 tablets after a high fat meal. The washout between each treatment is no less than 21 days.

Conditions: Healthy Volunteers
Being tested: TY-9591 Tablets under Fasted Condition - Arm1, Osimertinib Mesylate Tablets under Fasted Condition - Arm1, TY-9591 Tablets after a High-fat Meal - Arm1, Osimertinib Mesylate Tablets under Fasted Condition - Arm2, TY-9591 Tablets under Fasted Condition - Arm2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TY-9591 Tablets under Fasted Condition - Arm1Drug
Also called TY-9591
Phase 1 (period 1) fasted from 10 hours prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.
Osimertinib Mesylate Tablets under Fasted Condition - Arm1Drug
Also called AZD9291
Phase 1 (period 2) fasted from 10 hours prior to dosing with 80 mg Osimertinib Mesylate Tablets (p o, once) and 4 hours after dosing on day 1.
TY-9591 Tablets after a High-fat Meal - Arm1Drug
Also called TY-9591
Phase 2 (period 3) allocated high-fat meal prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.
Osimertinib Mesylate Tablets under Fasted Condition - Arm2Drug
Also called AZD9291
Phase 1 (period 1) fasted from 10 hours prior to dosing with 80 mg Osimertinib Mesylate Tablets (p o, once) and 4 hours after dosing on day 1.
TY-9591 Tablets under Fasted Condition - Arm2Drug
Also called TY-9591
Phase 1 (period 2) fasted from 10 hours prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.
TY-9591 Tablets after a High-fat Meal - Arm2Drug
Also called TY-9591
Phase 2 (period 3) allocated high-fat meal prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.

Study groups in NCT04798638
Study group	Role	What they receive
Arm1: TY-9591 + Osimertinib + TY-9591	Experimental	Participants will receive TY-9591 tablets under fasted condition in period 1 , followed by Osimeritinib Mesylate tablet under fasted condition in period 2. In period 3, participants will receive TY-9591 tablet in fed state (high-fat meal). The washout will be no less than 21 days between each treatment. Receives: Drug: TY-9591 Tablets under Fasted Condition - Arm1; Drug: Osimertinib Mesylate Tablets under Fasted Condition - Arm1; Drug: TY-9591 Tablets after a High-fat Meal - Arm1
Arm2: Osimertinib + TY-9591 + TY-9591	Experimental	Participants will receive Osimeritinib Mesylate tablet under fasted condition in period 1 , followed by TY-9591 tablets under fasted condition in period 2. In period 3, participants will receive TY-9591 tablet in fed state (high-fat meal). The washout will be no less than 21 days between each treatment. Receives: Drug: Osimertinib Mesylate Tablets under Fasted Condition - Arm2; Drug: TY-9591 Tablets under Fasted Condition - Arm2; Drug: TY-9591 Tablets after a High-fat Meal - Arm2

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of TY-9591 and its metabolites
Pharmacokinetics of TY-9591 and its metabolites (TY-9591-D1 (AZ5104) and TY-9591-D2) by assessment of the maximum plasma concentration.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Cmax of Osimertinib and its metabolites
Pharmacokinetics of Osimertinib and its metabolites (AZ5104 and AZ7550) by assessment of the maximum plasma concentration.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-72h) of TY-9591 and its metabolites
Pharmacokinetics of TY-9591 and its metabolites (TY-9591-D1 (AZ5104) and TY-9591-D2) by assessment of area under the plasma concentration time curve from zero to 72 hours.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-72h) of Osimertinib and its metabolites
Pharmacokinetics of Osimertinib and its metabolites (AZ5104 and AZ7550) by assessment of area under the plasma concentration time curve from zero to 72 hours.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.

Secondary outcomes (19)

Tmax of TY-9591 and its metabolites
Pharmacokinetics of TY-9591 and its metabolites by assessment of time to Cmax.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Tmax of Osimertinib and its metabolites
Pharmacokinetics of Osimertinib and its metabolites by assessment of time to Cmax.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
T1/2 of TY-9591 and its metabolites
Pharmacokinetics of TY-9591 and its metabolites by assessment of Terminal half life.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
T1/2 of Osimertinib and its metabolites
Pharmacokinetics of Osimertinib and its metabolites by assessment of Terminal half life.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
λz of TY-9591 and its metabolites
Pharmacokinetics of TY-9591 and its metabolites by assessment of Terminal rate constant.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
λz of Osimertinib and its metabolites
Pharmacokinetics of Osimertinib and its metabolites by assessment of Terminal rate constant.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-168h) of TY-9591 and its metabolites
Pharmacokinetics of TY-9591 and its metabolites by assessment of area under the plasma concentration time curve from zero to 168 hours.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-168h) of Osimertinib and its metabolites
Pharmacokinetics of Osimertinib and its metabolites by assessment of area under the plasma concentration time curve from zero to 168 hours.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-t) of TY-9591 and its metabolites
Pharmacokinetics of TY-9591 and its metabolites by assessment of area under the plasma concentration time curve from zero to appointed time.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-t) of Osimertinib and its metabolites
Pharmacokinetics of Osimertinib and its metabolites by assessment of area under the plasma concentration time curve from zero to appointed time.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-∞) of TY-9591 and its metabolites
Pharmacokinetics of TY-9591 and its metabolites by assessment of area under the plasma concentration time curve from zero to infinity.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-∞) of Osimertinib and its metabolites
Pharmacokinetics of Osimertinib and its metabolites by assessment of area under the plasma concentration time curve from zero to infinity.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
CL/F of TY-9591
Pharmacokinetics of TY-9591 only by assessment of apparent plasma clearance.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
CL/F of Osimertinib
Pharmacokinetics of Osimertinib only by assessment of apparent plasma clearance.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Vss/F of TY-9591
Pharmacokinetics of TY-9591 only apparent volume of distribution.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Vss/F of Osimertinib
Pharmacokinetics of Osimertinib only apparent volume of distribution.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Calculated for both Cmax and AUC of TY-9591
Pharmacokinetics of TY-9591 parent to metabolite ratio.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Calculated for both Cmax and AUC of Osimertinib
Pharmacokinetics of Osimertinib parent to metabolite ratio.
Measured: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Safety variables
Adverse events, clinical symptoms, vital signs, ECG's, clinical laboratory safety tests, ect.
Measured: Assessments performed throughout the study period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 20219 Sep 2021

First posted15 Mar 2021
Study start30 Apr 2021
Primary completion9 Sep 2021
Study completion9 Sep 2021

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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04798638
Sponsor's protocol ID: TYKM1601102
Status last verified: Aug 2021
First submitted: 11 Mar 2021
Last updated: 7 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Studies to Compare the Pharmacokinetics of TY-9591 Tablets and Osimertinib Mesylate Tablets After a Single Fasting Administration and Determine the Effect of Food on the Pharmacokinetics of TY-9591 Tablets in Healthy Volunteers
ClinicalTrials.gov ID: NCT04798638
Acronym / sponsor ID: TYKM1601102
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: TYK Medicines, IncIndustry (pharma, biotech, devices)
Study start: 30 Apr 2021 (actual)
Primary completion: 9 Sep 2021 (actual)
Study completion: 9 Sep 2021 (actual)
First posted: 15 Mar 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm1: TY-9591 + Osimertinib + TY-9591	Experimental	Drug: TY-9591 Tablets under Fasted Condition - Arm1, Drug: Osimertinib Mesylate Tablets under Fasted Condition - Arm1, Drug: TY-9591 Tablets after a High-fat Meal - Arm1Participants will receive TY-9591 tablets under fasted condition in period 1 , followed by Osimeritinib Mesylate tablet under fasted condition in period 2. In period 3, participants will receive TY-9591 tablet in fed state (high-fat meal). The washout will be no less than 21 days between each treatment.
Arm2: Osimertinib + TY-9591 + TY-9591	Experimental	Drug: Osimertinib Mesylate Tablets under Fasted Condition - Arm2, Drug: TY-9591 Tablets under Fasted Condition - Arm2, Drug: TY-9591 Tablets after a High-fat Meal - Arm2Participants will receive Osimeritinib Mesylate tablet under fasted condition in period 1 , followed by TY-9591 tablets under fasted condition in period 2. In period 3, participants will receive TY-9591 tablet in fed state (high-fat meal). The washout will be no less than 21 days between each treatment.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male must be ≥ 18 and ≤ 55 years of age.
Bodyweight of male must be ≥ 50.0 kg (bodyweight of female must be ≥ 45.0 kg), and the Body Mass Index must be ≥ 19.0 and ≤26.0 kg/m2.
The participants must have no birthing plan and agree to take adequate non-drug contraceptive measures within 2 weeks before screening to 6 months after the last drug treatment.
The participants have good communications with investigators, understand and comply with all requirements and fully understand and sign the informed consent form.
The results of physical examination, vital signs, ECG, laboratory examination and other relevant examination should compliance with the clinical protocol, or they will be recognized as non-clinical signs (NCS) if beyond the regulated range.

Key exclusion criteria (14 listed)

The participants who smoked daily >5 sticks of cigarette 3 months prior to screening or cannot give up smoking during study.
The participants consumed more than 14 units of alcohol per week (1 unit = 360 ml beers/45 ml liquor containing 40% alcohol/150 ml grape wine) 3 months prior to screening period, positive results of alcohol breath test and the volunteers who cannot give up drinking during study.
The participants who have overconsumption of tea, coffee, and the drink with caffeine (> 8 cup one day, 1 cup=250 ml) daily 3 months prior to screening period.
The participants have history of substance abuse and drug use within 6 months before screening.
The participants have history of chronic disease and serious illness in nervous system, vascular system, blood and lymphatic system, immune system, urinary system, respiratory system, digestive system and other metabolic system, any conditions and illness threat to the health of participants, and the history of hereditary disease.

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-9591 Tablets under Fasted Condition - Arm1Also: TY-9591Phase 1 (period 1) fasted from 10 hours prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.	Drug	Arm1: TY-9591 + Osimertinib + TY-9591
Osimertinib Mesylate Tablets under Fasted Condition - Arm1Also: AZD9291Phase 1 (period 2) fasted from 10 hours prior to dosing with 80 mg Osimertinib Mesylate Tablets (p o, once) and 4 hours after dosing on day 1.	Drug	Arm1: TY-9591 + Osimertinib + TY-9591
TY-9591 Tablets after a High-fat Meal - Arm1Also: TY-9591Phase 2 (period 3) allocated high-fat meal prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.	Drug	Arm1: TY-9591 + Osimertinib + TY-9591
Osimertinib Mesylate Tablets under Fasted Condition - Arm2Also: AZD9291Phase 1 (period 1) fasted from 10 hours prior to dosing with 80 mg Osimertinib Mesylate Tablets (p o, once) and 4 hours after dosing on day 1.	Drug	Arm2: Osimertinib + TY-9591 + TY-9591
TY-9591 Tablets under Fasted Condition - Arm2Also: TY-9591Phase 1 (period 2) fasted from 10 hours prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.	Drug	Arm2: Osimertinib + TY-9591 + TY-9591
TY-9591 Tablets after a High-fat Meal - Arm2Also: TY-9591Phase 2 (period 3) allocated high-fat meal prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.	Drug	Arm2: Osimertinib + TY-9591 + TY-9591

Primary outcome

Cmax of TY-9591 and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Pharmacokinetics of TY-9591 and its metabolites (TY-9591-D1 (AZ5104) and TY-9591-D2) by assessment of the maximum plasma concentration.
Cmax of Osimertinib and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Pharmacokinetics of Osimertinib and its metabolites (AZ5104 and AZ7550) by assessment of the maximum plasma concentration.
AUC(0-72h) of TY-9591 and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Pharmacokinetics of TY-9591 and its metabolites (TY-9591-D1 (AZ5104) and TY-9591-D2) by assessment of area under the plasma concentration time curve from zero to 72 hours.
AUC(0-72h) of Osimertinib and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Pharmacokinetics of Osimertinib and its metabolites (AZ5104 and AZ7550) by assessment of area under the plasma concentration time curve from zero to 72 hours.

19 secondary outcomes

Tmax of TY-9591 and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Tmax of Osimertinib and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
T1/2 of TY-9591 and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
T1/2 of Osimertinib and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
λz of TY-9591 and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
λz of Osimertinib and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-168h) of TY-9591 and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-168h) of Osimertinib and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-t) of TY-9591 and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-t) of Osimertinib and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-∞) of TY-9591 and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
AUC(0-∞) of Osimertinib and its metabolites
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
CL/F of TY-9591
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
CL/F of Osimertinib
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Vss/F of TY-9591
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Vss/F of Osimertinib
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Calculated for both Cmax and AUC of TY-9591
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Calculated for both Cmax and AUC of Osimertinib
Time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.
Safety variables
Time frame: Assessments performed throughout the study period.

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 7 Dec 2022.
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.

Kunyan Li, Ph.D principal investigator

Hunan Provincial Tumor Hospital

Xue Chen, MD principal investigator

Hunan Provincial Tumor Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 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 7 Dec 2022. 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?

Cmax of TY-9591 and its metabolites (time frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04798638.

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 7 Dec 2022.