Healthy Adult SubjectPhase 1NCT07341672
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
A Phase 1 study testing Clifutinib, Itraconazole and fluconazole in people with Healthy Adult Subject, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subject
- What is being tested?
- Clifutinib, Itraconazole and fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2026to 8 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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.
- 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.
- Male or female participants aged 18 to 50 years old (including 18 and 50 years old).
- 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).
Who cannot join
- 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.
- 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.
- Any positive of hepatitis B surface antigen, hepatitis C antibody, AIDS antibody, or treponema pallidum antibody.
- The female participants were pregnant or lactating, and the blood pregnancy results at screening and admission exceeded the upper limit of the normal value.
- Taking any prescription medication, over-the-counter medication, any vitamin product, or herbal medicine within 14 days before screening.
- Taking any drugs that alter liver enzyme activity, such as barbiturates, rifampicin, within 30 days before screening.
Show all 23Show fewer
- Taking an inhibitor or inducer of CYP3A4 within 30 days before screening.
- 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.
- Received a vaccination within 28 days before screening or planned to be vaccinated during the trial.
- Blood donation or blood loss >450 mL within 3 months before screening; Or planned to donate blood during the trial.
- 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.
- Suffering from any condition that increases the risk of bleeding, such as active hemorrhoids bleeding, acute gastritis or gastric and duodenal ulcers.
- 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.
- Acute illness or concomitant medication occurred from the date of signing the informed consent to the date of first administration of the investigational drug.
- Allergic constitution (multiple drugs and food allergy), allergic to Clifutinib or any drug component, allergic to itraconazole, fluconazole and efavirenz or any drug component.
- 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.
- 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.
- Those with a positive urine drug screen or who had a history of drug abuse or drug use in the past 5 years.
- 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.
- 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.
- Those who have special requirements for diet and cannot accept a uniform diet.
- 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.
- Participants were deemed by the investigator to be ineligible for the trial for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Jinan, Shandong, 250000
About this study
Official title: 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.
- Conditions
- Healthy Adult Subject
- Being tested
- Clifutinib, Itraconazole, fluconazole, efavirenz
- Keywords
- Clifutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClifutinibDrug
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.
ItraconazoleDrug
Itraconazole is taken orally approximately 30 minutes after the start of breakfast and lunch.
fluconazoleDrug
Take fluconazole on an empty stomach
efavirenzDrug
Take efavirenz on an empty stomach
| Study group | Role | What they receive |
|---|---|---|
| Clifutinib | Experimental | On Day 1, subjects will receive a single dose of 40 mg Clifutinib Receives: Drug: Clifutinib |
| Clifutinib and Itraconazole | Active comparator | From Day 1 to Day 49, subjects will receive Itraconazole 200mg bid, and receive single dose of 40mg Clifutinib on Day 8 Receives: Drug: Clifutinib; Drug: Itraconazole |
| Clifutinib and Fluconazole | Active comparator | From Day 1 to Day 49, subjects will receive Fluconazole 400mg qd, and receive single dose of 40mg Clifutinib on Day 8 Receives: Drug: Clifutinib; Drug: fluconazole |
| Clifutinib and Efavirenz | Active comparator | From Day 1 to Day 49, subjects will receive Efavirenz 600mg qd, and receive single dose of 40mg Clifutinib on Day 8 Receives: Drug: Clifutinib; Drug: efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Measured: From Day1 to Day50
AUC0-t
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Measured: From Day1 to Day50
AUC0-∞
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Measured: From Day1 to Day50
%AUCex
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Measured: From Day1 to Day50
Tmax
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Measured: From Day1 to Day50
t1/2
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Measured: From Day1 to Day50
Secondary outcomes (5)
Adverse event
Frequency, type and severity of adverse events/serious adverse events.
Measured: From Day1 to Day50
ECG（Electrocardiogram）
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.
Measured: From Day1 to Day50
Body temperature
Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Measured: From Day1 to Day50
Blood pressure
Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Measured: From Day1 to Day50
Pulse
Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Measured: From Day1 to Day50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start31 Dec 2026 (estimated)
- Primary completion23 Apr 2027 (estimated)
- Study completion8 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectStudies 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341672
- Sponsor's protocol ID
- HEC73543-AML-105
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 27 Apr 2026
- 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Drug-Drug Interaction Study of Clifutinib
- ClinicalTrials.gov ID
- NCT07341672
- Acronym / sponsor ID
- HEC73543-AML-105
- Conditions
- Healthy Adult Subject
- Keywords
- Clifutinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 23 Apr 2027 (estimated)
- Study completion
- 8 May 2027 (estimated)
- First posted
- 14 Jan 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clifutinib | Experimental | Drug: ClifutinibOn Day 1, subjects will receive a single dose of 40 mg Clifutinib |
| Clifutinib and Itraconazole | Active comparator | Drug: Clifutinib, Drug: ItraconazoleFrom Day 1 to Day 49, subjects will receive Itraconazole 200mg bid, and receive single dose of 40mg Clifutinib on Day 8 |
| Clifutinib and Fluconazole | Active comparator | Drug: Clifutinib, Drug: fluconazoleFrom Day 1 to Day 49, subjects will receive Fluconazole 400mg qd, and receive single dose of 40mg Clifutinib on Day 8 |
| Clifutinib and Efavirenz | Active comparator | Drug: Clifutinib, Drug: efavirenzFrom Day 1 to Day 49, subjects will receive Efavirenz 600mg qd, and receive single dose of 40mg Clifutinib on Day 8 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- 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.
- Male or female participants aged 18 to 50 years old (including 18 and 50 years old).
- 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).
Key exclusion criteria (23 listed)
- 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.
- 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.
- Any positive of hepatitis B surface antigen, hepatitis C antibody, AIDS antibody, or treponema pallidum antibody.
- The female participants were pregnant or lactating, and the blood pregnancy results at screening and admission exceeded the upper limit of the normal value.
- Taking any prescription medication, over-the-counter medication, any vitamin product, or herbal medicine within 14 days before screening.
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 |
|---|---|---|
| ClifutinibThe 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 | Clifutinib, Clifutinib and Efavirenz, Clifutinib and Fluconazole, Clifutinib and Itraconazole |
| ItraconazoleItraconazole is taken orally approximately 30 minutes after the start of breakfast and lunch. | Drug | Clifutinib and Itraconazole |
| fluconazoleTake fluconazole on an empty stomach | Drug | Clifutinib and Fluconazole |
| efavirenzTake efavirenz on an empty stomach | Drug | Clifutinib and Efavirenz |
Primary outcome
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.
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.
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.
%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.
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.
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.
5 secondary outcomes
Adverse event
Time frame: From Day1 to Day50
ECG（Electrocardiogram）
Time frame: From Day1 to Day50
Body temperature
Time frame: From Day1 to Day50
Blood pressure
Time frame: From Day1 to Day50
Pulse
Time frame: From Day1 to Day50
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- 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.
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 Clifutinib, Itraconazole and fluconazole in people with Healthy Adult Subject, run by Sunshine Lake Pharma 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 4 inclusion and 23 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: opening soon, as of the sponsor's last update on 27 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhao, Doctor (+86 0531-89268212, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: From Day1 to Day50). The study lists 6 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 27 Apr 2026.