A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Itraconazole Capsules (ICZ)

NCT07001501 | Completed Phase 1

• 1 other identifier: KHYQZX-022-2021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase (RdRp). This is a clinical study to evaluate the Interactions between Azvudine Tablets (FNC) and Itraconazole Capsules (ICZ) in healthy subjects. This is a single-center, randomized, open-label, three-cycles, three-treatment crossover clinical trial. Subjects was administered orally for 10 consecutive days each cycle, and the washout period between each cycle was 14 days. Biological sample collection and safety examination were performed.

Conditions

Healthy

Keywords

Azvudine

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax, ss) of Azvudine and Itraconazole

  Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 of the study.

• Pharmacokinetics (PK): Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of Azvudine and Itraconazole

  Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 of the study.

• Pharmacokinetics (PK): Elimination of Terminal Half-Life (t1/2) of Azvudine and Itraconazole

  Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 of the study.

Secondary Outcomes (1)

• Occurrence of Adverse Events

  From enrollment to the end of the study on Day 59.

Study Arms (3)

Group 1 : FNC+ICZ;FNC;ICZ

EXPERIMENTAL

Drug: Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)

Group 2 : ICZ;FNC+ICZ; FNC

EXPERIMENTAL

Drug: Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)

Group 3 : FNC; ICZ; FNC+ICZ

EXPERIMENTAL

Drug: Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)

Interventions

Azvudine tablets(FNC) and Itraconazole Capsules (ICZ) DRUG

This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days; ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days.

Group 1 : FNC+ICZ;FNC;ICZ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female subjects aged 18 years or older (including 18 years) with an appropriate ratio of male to female participants;
• The weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg. Body mass index (BMI) within the range of 19.0-26.0 (including the critical value).;
• All fertile male and female subjects agreed to take appropriate and effective physical contraceptive measures from the screening period until the end of the trial, and to use effective physical and/or pharmacological contraceptive measures for 6 months after the trial ends, with no plans for sperm or egg donation;
• Subjects fully understand the purpose, nature, process of the trial, and the potential adverse reactions, voluntarily agree to participate as subjects, and sign an informed consent form prior to the commencement of all study procedures;
• Subjects must be able to communicate effectively with the researchers and understand and comply with all requirements of this study.

You may not qualify if:

• Individuals with allergic constitutions, a history of drug or food allergies, especially those allergic to any components of this product and its excipients;
• Individuals with a previous history of hypoglycemia;
• Individuals who have abnormal results from physical examinations, vital signs check, clinical laboratory tests, 12-lead electrocardiograms, and other pre-trial relevant examinations, deemed clinically significant by the clinical researcher, and considered unqualified (normal reference range for vital signs: systolic blood pressure \<90 mmHg or \>140 mmHg, diastolic blood pressure \<60 mmHg or \>90 mmHg; pulse \<60 bpm or \>100 bpm);
• Individuals with a history of alcohol abuse within the 12 months prior to screening (consuming ≥14 units of alcohol weekly: 1 unit = 285 ml of beer, or 25 ml of spirits, or 150 ml of wine) or those with positive alcohol breath test results before enrollment (test value \>0 mg/100 ml);
• Individuals with a history of drug abuse or use of illicit substances within the 12 months prior to screening, including repeated or excessive use of various anesthetics and psychoactive substances, addictive drugs \[MDMA (Ecstasy), Methamphetamine (Ice), Ketamine, Morphine, THC (Marijuana)\] or those with a positive result on the five-panel drug test before enrollment;
• Individuals who had undergone surgery within 3 months prior to screening, especially those who had surgeries affecting drug absorption, distribution, metabolism, or excretion, or who plan to undergo surgery during the study;
• Individuals who had used any drug that interacts with the trial medication within 30 days prior to screening, such as methadone, disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (such as dihydroergotamine, ergometrine, ergotamine, methylergometrine), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin, ticagrelor, CYP3A4 medium or strong inducers such as levoacemesadol, halofantrine, astemizole, imidolastine, terfenadine, serindole, benzylprodil, lecadipine, ivabradidine, domperidone and other CYP3A4 medium or strong inducers or CYP3A4/P-glycoprotein/BCRP substrates and erythromycin, azithromycin, levoxacin, etc.;
• Individuals with a past medical history of cardiovascular, liver, kidney, pulmonary, gastrointestinal, neurological diseases, particularly any surgical conditions or diseases that might affect drug absorption, distribution, metabolism, and excretion, or conditions that could pose risks to trial participants;
• Individuals with a history of mental illness (e.g., anxiety, depression);
• Individuals with febrile illnesses within 3 days prior to screening;
• Individuals who had received a novel coronavirus vaccine within 14 days prior to screening or received any other vaccine within 3 months prior to screening, or planed to receive a vaccine during the study;
• Individuals who had participated in other clinical trials and received medication within 3 months prior to screening;
• Individuals who consumed excessive amounts of tea, coffee, and/or beverages rich in caffeine, theobromine, and alcohol (more than 8 cups, with 1 cup = 250 ml) within 3 months prior to screening;
• Individuals who had used any prescription medications, over-the-counter drugs, herbal medicines, dietary supplements, and functional vitamins within 14 days before the first dose;
• Individuals who smoked an average of more than 5 cigarettes daily within 3 months prior to the first dose;

Sponsors & Collaborators

• Henan Genuine Biotech Co., Ltd.: lead

Study Sites (1)

Phase I Clinical Trial Research Center of Dongguan Kanghua Hospital

Guangdong, China

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: February 21, 2022
• Primary Completion: April 25, 2022
• Study Completion: March 13, 2023
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

CN (1)