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

NCT07341672 | Not Yet Recruiting Phase 1

• 1 other identifier: HEC73543-AML-105
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Subject

Keywords

Clifutinib

Outcome Measures

Primary Outcomes (6)

• Cmax

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

  From Day1 to Day50

• AUC0-t

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

  From Day1 to Day50

• AUC0-∞

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

  From Day1 to Day50

• %AUCex

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

  From Day1 to Day50

• Tmax

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

  From Day1 to Day50

• t1/2

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

  From Day1 to Day50

Secondary Outcomes (5)

• Adverse event

  From Day1 to Day50

• ECG（Electrocardiogram）

  From Day1 to Day50

• Body temperature

  From Day1 to Day50

• Blood pressure

  From Day1 to Day50

• Pulse

  From Day1 to Day50

Study Arms (4)

Clifutinib

EXPERIMENTAL

On Day 1, subjects will receive a single dose of 40 mg Clifutinib

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

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

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

Drug: Clifutinib; Drug: efavirenz

Interventions

Clifutinib DRUG

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.

Clifutinib; Clifutinib and Efavirenz; Clifutinib and Fluconazole; Clifutinib and Itraconazole

Itraconazole DRUG

Itraconazole is taken orally approximately 30 minutes after the start of breakfast and lunch.

Clifutinib and Itraconazole

fluconazole DRUG

Take fluconazole on an empty stomach

Clifutinib and Fluconazole

efavirenz DRUG

Take efavirenz on an empty stomach

Clifutinib and Efavirenz

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)

Jinan, Shandong, 250000, China

Location

MeSH Terms

Interventions

Itraconazole; Fluconazole; efavirenz

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Central Study Contacts

Wei Zhao, Doctor

CONTACT

+86 0531-89268212; zhao4wei2@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Clifutinib,Itraconazole, Fluconazole, Efavirenz
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 14, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): April 23, 2026
• Study Completion (Estimated): May 8, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)