Locally Advanced or Metastatic NSCLCPhase 1NCT05631678

Drug-drug Interaction Study Beteewn ASK120067 and Rifampicin or Itraconazole

A Phase 1 study testing Rifampicin; ASK120067 and ASK120067;itraconazole in people with Locally Advanced or Metastatic NSCLC, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. 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

Search all trials

Trial summary

To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of ASK120067 and its metabolite CCB4580030 in healthy subjects. To evaluate the safety of ASK120067 tablets or combination with rifampicin capsules or itraconazole capsules in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Locally Advanced or Metastatic NSCLC
What is being tested?: Rifampicin; ASK120067 and ASK120067;itraconazole
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: 6 Jun 2022to 3 Aug 2022
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
Healthy volunteers accepted
Adult

Who may be able to join

healthy adult subjects, male and female;
Age: 18-45 years old (including boundary value);
Body weight: body mass index (BMI) between 18.5 and 26.0 kg/m2 (including boundary values);
Subjects are willing to sign the informed consent;
Subjects are able to communicate well with investigators and complete the clinical trial in according to the protocol.

Who cannot join

patients with clinical significance who are abnormal by comprehensive physical examination, vital signs examination, routine laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram, and positive and lateral chest radiographs;
HBSAg HCVAb HIVAb, and treponema palliatum antibody test results were positive;
taking any drugs that inhibit or induce hepatic metabolism of drugs (especially CYP3A4, CYP2C8, CYP2C9 and CYP2C19) within 30 days before the screening period (e.g., inducers - barbiturates, carbamazepine, phenytoin, rifampicin, glucocorticoids, rifabutin, PPI inhibitors; Inhibitors: SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, nitroimidazoles, sedative hypnotics, fluoroquinolones, antihistamines);'
taking any medication 14 days before the trial;
taking any investigational drug or participating in any investigational drug within 3 months before the screening period;
previous history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torssion ventricular tachycardia, ventricular tachycardia, long QT syndrome or symptoms of long QT syndrome and family history (genetic proof or sudden death of a close relative at young age);

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major surgery within 6 months before the screening period or surgical incision did not heal completely;
history of any clinically serious illness or disease or condition considered by the investigators to be likely to affect the results of the trial, including but not limited to a history of cardiac, respiratory, endocrine, nervous, digestive, urinary, or hematologic, immunologic, psychiatric, or metabolic diseases;
specific allergic history (asthma, measles, eczema, etc.) or allergic constitution (presence of two or more allergens), or allergic to EGFR receptor inhibitor drugs or any component of the trial drugs; allergic to any food ingredients or have special requirements for diet and cannot abide by the uniform diet;
smoking more than 5 cigarettes per day within 3 months before screening period and unable to quit during the trial;
Heavy drinking or regular drinking within 3 months before the screening period, defined as drinking more than 14 units of alcohol per week (1 unit =360ml of beer or 45 ml of 40% spirits or 150 ml of wine); Or alcohol breath test > 0.0mg /100mLduring screening;
history of drugs use or drugs abuse screening positive;
special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or drank excessive tea, coffee, grapefruit/grapefruit juice and/or caffeinated beverages (more than 8 cups per day, 200 mL per cup on average) within 2 weeks before the first dose of research medication;
Pregnant or lactating women, or pregnancy screening positive;
Sujects plan to have a child during the trial or within 6 months after completion of the trial, or do not agree that heself /herself and his/her spouse use strict contraception (condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, or other contraceptive methods) during the trial and within 6 months after completion of the trial.
History of lost blood or donated a blood volume of 400 mL within 3 months before the screening period or planing to donate blood within 1 month after the end of the trial;
Subjects were vaccinated within 15 days before screening or planing to be vaccinated during the trial, or have not been vaccinated against COVID-19;
Subjects may be unable to complete the study for other reasons or may be considered inappropriate by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Drum Tower Hospital of Nanjing University School of Medical
Nanjing, Jiangsu

Other trials in China

About this study

Official title: An Open-lable, Two- Period, Single-sequence, Self-controlled Study to Evaluate the Effect of Oral Rifampicin or Itraconazole on the Pharmacokinetics of ASK120067 Tablets

To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of ASK120067 and its metabolite CCB4580030 in healthy subjects.

To evaluate the safety of ASK120067 tablets or combination with rifampicin capsules or itraconazole capsules in healthy subjects.

Conditions: Locally Advanced or Metastatic NSCLC
Being tested: Rifampicin; ASK120067, ASK120067;itraconazole
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

Rifampicin; ASK120067Drug
Take ASK120067 tablets orally once on the first day at 160mg in fast condition;Take rifampicin capsules orally once on the days 8 to 17 at 600mg in fast condition, and a combination of 160mg ASk120067 and 600mg rifampicin were administrated on the 15th day in fast condition.
ASK120067;itraconazoleDrug
Take ASK120067 tablets orally once on the first day at 80mg in fast condition;Take itraconazole capsules orally twice on the days 8 to 13 at 200mg in fed condition, and a combination of 80mg ASK120067 and 200mg itraconazole were administrated on the 11th day in fast condition.

Study groups in NCT05631678
Study group	Role	What they receive
the effect of oral rifampicin on the pharmacokinetics of ASK120067 tablets	Experimental	Take ASK120067 tablets orally once on the first day at 160mg in fast condition；Take rifampicin capsules orally once on the days 8 to 17 at 600mg in fast condition, and a combination of 160mg ASK120067 and 600mg rifampicin were administrated on the 15th day in fast condition. Receives: Drug: Rifampicin; ASK120067
effect of oral itraconazole on the pharmacokinetics of ASK120067 tablets	Experimental	Take ASK120067 tablets orally once on the first day at 80mg in fast condition；Take itraconazole capsules orally twice on the days 8 to 13 at 200mg in fed condition, and a combination of 80mg ASK120067 and 200mg itraconazole were administrated on the 11th day in fast condition. Receives: Drug: ASK120067;itraconazole

What is being measured

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

Cmax
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points after the administration of ASK120067 in each period to figure out maximum concentration
Measured: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
AUC
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points after the administration of ASK120067 in each period to figure out area under the plasma concentration-time curve
Measured: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)

Secondary outcomes (6)

Tmax
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points after the administration of ASK120067 in each period to figure out time to reach maximum concentration
Measured: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
t1/2
Blood samples will be collected from each subject at pre-specified times after the administration of ASK120067 in each period, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
Measured: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
CL/F
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points after the administration of ASK120067 in each period to figure out apparent clearance
Measured: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
Vd/F
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points after the administration of ASK120067 in each period to figure out apparent volume of distribution
Measured: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
λz
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points after the administration of ASK120067 in each period to figure out apparent terminal elimination rate constant
Measured: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
Incidence and Severity of Treatment-Emergent Adverse Events
Assessed by number and severity of adverse events as recorded on the case report form
Measured: Adverse events will be collected from baseline until 18 days of arm A or 14 days of arm B after the first dose administration and the follow-up period

Timeline

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

6 Jun 20223 Aug 2022

First posted30 Nov 2022
Study start6 Jun 2022
Primary completion3 Aug 2022
Study completion3 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Locally Advanced or Metastatic 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05631678
Sponsor's protocol ID: ASK120067-PK-1
Status last verified: Nov 2022
First submitted: 11 Nov 2022
Last updated: 30 Nov 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Cao B, Huang L, Liu M, Lin H, Ma T, Zhao Y, Geng Y, Yang Y, Guo H, Li J. Phase 1 study to evaluate the effects of rifampin or itraconazole on the pharmacokinetics of limertinib (ASK120067), a novel mutant-selective inhibitor of the epidermal growth factor receptor in healthy Chinese subjects. Expert Opin Drug Metab Toxicol. 2023 Sep;19(9):653-664. doi: 10.1080/17425255.2023.2260738. Epub 2023 Oct 12.
PubMed 37811634

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?

See locations

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All Locally Advanced or Metastatic NSCLC trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-lable, Two- Period, Single-sequence, Self-controlled Study to Evaluate the Effect of Oral Rifampicin or Itraconazole on the Pharmacokinetics of ASK120067 Tablets
ClinicalTrials.gov ID: NCT05631678
Acronym / sponsor ID: ASK120067-PK-1
Conditions: Locally Advanced or Metastatic NSCLC
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 6 Jun 2022 (actual)
Primary completion: 3 Aug 2022 (actual)
Study completion: 3 Aug 2022 (actual)
First posted: 30 Nov 2022 (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.

To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of ASK120067 and its metabolite CCB4580030 in healthy subjects.

To evaluate the safety of ASK120067 tablets or combination with rifampicin capsules or itraconazole capsules in healthy subjects.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
the effect of oral rifampicin on the pharmacokinetics of ASK120067 tablets	Experimental	Drug: Rifampicin; ASK120067Take ASK120067 tablets orally once on the first day at 160mg in fast condition；Take rifampicin capsules orally once on the days 8 to 17 at 600mg in fast condition, and a combination of 160mg ASK120067 and 600mg rifampicin were administrated on the 15th day in fast condition.
effect of oral itraconazole on the pharmacokinetics of ASK120067 tablets	Experimental	Drug: ASK120067;itraconazoleTake ASK120067 tablets orally once on the first day at 80mg in fast condition；Take itraconazole capsules orally twice on the days 8 to 13 at 200mg in fed condition, and a combination of 80mg ASK120067 and 200mg itraconazole were administrated on the 11th day in fast condition.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

healthy adult subjects, male and female;
Age: 18-45 years old (including boundary value);
Body weight: body mass index (BMI) between 18.5 and 26.0 kg/m2 (including boundary values);
Subjects are willing to sign the informed consent;
Subjects are able to communicate well with investigators and complete the clinical trial in according to the protocol.

Key exclusion criteria (18 listed)

patients with clinical significance who are abnormal by comprehensive physical examination, vital signs examination, routine laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram, and positive and lateral chest radiographs;
HBSAg HCVAb HIVAb, and treponema palliatum antibody test results were positive;
taking any drugs that inhibit or induce hepatic metabolism of drugs (especially CYP3A4, CYP2C8, CYP2C9 and CYP2C19) within 30 days before the screening period (e.g., inducers - barbiturates, carbamazepine, phenytoin, rifampicin, glucocorticoids, rifabutin, PPI inhibitors; Inhibitors: SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, nitroimidazoles, sedative hypnotics, fluoroquinolones, antihistamines);'
taking any medication 14 days before the trial;
taking any investigational drug or participating in any investigational drug within 3 months before the screening 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
Rifampicin; ASK120067Take ASK120067 tablets orally once on the first day at 160mg in fast condition;Take rifampicin capsules orally once on the days 8 to 17 at 600mg in fast condition, and a combination of 160mg ASk120067 and 600mg rifampicin were administrated on the 15th day in fast condition.	Drug	the effect of oral rifampicin on the pharmacokinetics of ASK120067 tablets
ASK120067;itraconazoleTake ASK120067 tablets orally once on the first day at 80mg in fast condition;Take itraconazole capsules orally twice on the days 8 to 13 at 200mg in fed condition, and a combination of 80mg ASK120067 and 200mg itraconazole were administrated on the 11th day in fast condition.	Drug	effect of oral itraconazole on the pharmacokinetics of ASK120067 tablets

Primary outcome

Cmax
Time frame: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points after the administration of ASK120067 in each period to figure out maximum concentration
AUC
Time frame: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points after the administration of ASK120067 in each period to figure out area under the plasma concentration-time curve

6 secondary outcomes

Tmax
Time frame: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
t1/2
Time frame: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
CL/F
Time frame: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
Vd/F
Time frame: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
λz
Time frame: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)
Incidence and Severity of Treatment-Emergent Adverse Events
Time frame: Adverse events will be collected from baseline until 18 days of arm A or 14 days of arm B after the first dose administration and the follow-up 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 30 Nov 2022.
Derived from this study: PubMed 37811634Cao B, Huang L, Liu M, Lin H, Ma T, Zhao Y, Geng Y, Yang Y, Guo H, Li J. Phase 1 study to evaluate the effects of rifampin or itraconazole on the pharmacokinetics of limertinib (ASK120067), a novel mutant-selective inhibitor of the epidermal growth factor receptor in healthy Chinese subjects. Expert Opin Drug Metab Toxicol. 2023 Sep;19(9):653-664. doi: 10.1080/17425255.2023.2260738. Epub 2023 Oct 12.
Individual participant dataSharing planned: Undecided

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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.

Juan Li principal investigator

Drum Tower Hospital of Nanjing University School of Medical

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 Rifampicin; ASK120067 and ASK120067;itraconazole in people with Locally Advanced or Metastatic NSCLC, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. 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 18 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 Nov 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 (time frame: Blood samples will be collected from each subject after the administration of ASK120067 on Day 1 and Day 15 in arm A ,and on Day 1 and Day 11 in arm B (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 h post dose)). The study lists 2 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 NCT05631678, which also lists 1 linked publication.

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 Nov 2022.