A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itraconazole, Fluconazole or Efavirenz on a Single Dose of Clifutinib in Healthy Participants

April 24, 2026 updated by: Sunshine Lake Pharma Co., Ltd.

The Drug-Drug Interaction Study of Clifutinib

Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib and the safety of the combination therapy in healthy participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Informed consents were signed voluntarily with full understanding of the trial content, process and possible adverse reactions. Be able to complete the trial according to the requirements of the trial protocol.
  2. Have no plans of fertility, sperm retrieval or egg donation during the trial, and are willing to take effective contraceptive measures within 6 months from the date of signing ICF to the end of drug administration.
  3. Male or female participants aged 18 to 50 years old (including 18 and 50 years old).
  4. Male participants weighed at least 50 kg and female participants weighed at least 45 kg. Body mass index (BMI) = weight (kg)/height2 (m2), with BMI in the range of 18 to 28 kg/m2 (including cutoff).

Exclusion Criteria:

  1. During the screening period, physical examination, vital signs, laboratory tests(blood routine, blood biochemistry, coagulation function, urine routine), chest X-ray, abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney), ophthalmic examination and other examinations were abnormal and had clinical significance.
  2. QTcF was calculated with Fridericia's correction formula QTcF = QT/RR (RR^0.33=60/ heart rate (BPM)) in patients with abnormal 12-lead electrocardiogram (ECG) or corrected QT interval (QTcF) >450 ms.
  3. Any positive of hepatitis B surface antigen, hepatitis C antibody, AIDS antibody, or treponema pallidum antibody.
  4. The female participants were pregnant or lactating, and the blood pregnancy results at screening and admission exceeded the upper limit of the normal value.
  5. Taking any prescription medication, over-the-counter medication, any vitamin product, or herbal medicine within 14 days before screening.
  6. Taking any drugs that alter liver enzyme activity, such as barbiturates, rifampicin, within 30 days before screening.
  7. Taking an inhibitor or inducer of CYP3A4 within 30 days before screening.
  8. Were enrolled in a clinical trial of any drug within 3 months before screening and used a trial drug, or were planning to enroll in another clinical trial during the trial.
  9. Received a vaccination within 28 days before screening or planned to be vaccinated during the trial.
  10. Blood donation or blood loss >450 mL within 3 months before screening; Or planned to donate blood during the trial.
  11. Patients with dysphagia or a gastrointestinal, hepatic, or renal disease (whether cured or not) within 6 months before screening that can affect drug absorption or excretion.
  12. Suffering from any condition that increases the risk of bleeding, such as active hemorrhoids bleeding, acute gastritis or gastric and duodenal ulcers.
  13. Patients with past or present serious or chronic diseases of digestive system, urinary system, respiratory system, circulatory system, nervous system, blood system, endocrine system, immune system, mental system, etc.
  14. Acute illness or concomitant medication occurred from the date of signing the informed consent to the date of first administration of the investigational drug.
  15. Allergic constitution (multiple drugs and food allergy), allergic to Clifutinib or any drug component, allergic to itraconazole, fluconazole and efavirenz or any drug component.
  16. The average daily smoking was more than 5 cigarettes in the 3 months before the trial, or the habitual use of nicotine-containing products, and could not quit during the trial.
  17. If they had a history of alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or were unable to abstain from alcohol during the study period, or had an alcohol breath test result greater than 0 mg per 100 mL.
  18. Those with a positive urine drug screen or who had a history of drug abuse or drug use in the past 5 years.
  19. Ingested chocolate, any caffeinated or xanthine-rich food or drink within 24 hours before taking the test drug, or were unable to stop taking it during the trial.
  20. Had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 14 days before screening, or could not stop taking special diet or strenuous exercise during the trial; Or other factors affecting drug absorption, distribution, metabolism and excretion as judged by the researchers.
  21. Those who have special requirements for diet and cannot accept a uniform diet.
  22. Those who had a history of faintness in needles or blood, who had difficulty in blood collection or could not tolerate blood collection by venipuncture, or who had poor evaluation of venous blood collection.
  23. Participants were deemed by the investigator to be ineligible for the trial for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Clifutinib
On Day 1, subjects will receive a single dose of 40 mg Clifutinib
Drug: Clifutinib
The subjects are required to take Clifutinib on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour.
Active Comparator: Clifutinib and Itraconazole
From Day 1 to Day 49, subjects will receive Itraconazole 200mg bid, and receive single dose of 40mg Clifutinib on Day 8
Drug: Clifutinib
The subjects are required to take Clifutinib on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour.
Drug: Itraconazole
Itraconazole is taken orally approximately 30 minutes after the start of breakfast and lunch.
Active Comparator: Clifutinib and Fluconazole
From Day 1 to Day 49, subjects will receive Fluconazole 400mg qd, and receive single dose of 40mg Clifutinib on Day 8
Drug: Clifutinib
The subjects are required to take Clifutinib on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour.
Drug: fluconazole
Take fluconazole on an empty stomach
Active Comparator: Clifutinib and Efavirenz
From Day 1 to Day 49, subjects will receive Efavirenz 600mg qd, and receive single dose of 40mg Clifutinib on Day 8
Drug: Clifutinib
The subjects are required to take Clifutinib on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour.
Drug: efavirenz
Take efavirenz on an empty stomach

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: From Day1 to Day50
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
From Day1 to Day50
AUC0-t
Time Frame: From Day1 to Day50
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
From Day1 to Day50
AUC0-∞
Time Frame: From Day1 to Day50
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
From Day1 to Day50
%AUCex
Time Frame: From Day1 to Day50
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
From Day1 to Day50
Tmax
Time Frame: From Day1 to Day50
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
From Day1 to Day50
t1/2
Time Frame: From Day1 to Day50
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
From Day1 to Day50

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse event
Time Frame: From Day1 to Day50
Frequency, type and severity of adverse events/serious adverse events.
From Day1 to Day50
ECG（Electrocardiogram）
Time Frame: From Day1 to Day50
Evaluation parameters include heart rate, PR interval, QTcF and QRS interval, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
From Day1 to Day50
Body temperature
Time Frame: From Day1 to Day50
Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
From Day1 to Day50
Blood pressure
Time Frame: From Day1 to Day50
Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
From Day1 to Day50
Pulse
Time Frame: From Day1 to Day50
Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
From Day1 to Day50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunshine Lake Pharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HEC73543-AML-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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