Clinical trial NCT05147727: Drug-drug Interaction Study Between Fluconazole and Famitinib in Healthy Subjects
Official title: A Single-center, Open-label, Fixed-sequence Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of Famitinib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fluconazole and famitinib interaction
Primary purpose: BASIC_SCIENCE

Brief summary: An open-label, fixed-sequence, drug-drug interaction study to evaluate the effects of fluconazole on the pharmacokinetics and safety of famitinib in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. With my consent and informed consent, I am willing and able to complete the study in accordance with the requirements of the experimental protocol;
2. Healthy male or female aged 18-45 years (including threshold) on the date of signing the informed consent form;
3. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value);
4. Physical examination, vital signs, laboratory measurements (blood routine, blood biochemistry, urine routine test, coagulation function, etc.), 12-lead ECG, abdominal B-ultrasound, chest X-ray, etc. are normal or abnormal, but the researcher has no clinical significance according to NCI CTCAE 5.0 standard;
5. Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 3 months from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women within 24 hours before the first administration of the study drug should be negative.

Exclusion Criteria:

1. Those who have previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, which are judged by the researchers to be unsuitable for the trial;
2. Subjects who have received any previous operation affecting gastrointestinal absorption;
3. Subjects who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
4. Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
5. HBsAg positive, HCVAb positive, HIV antibody positive, syphilis antibody positive;
6. History of drug use in the past 5 years or drug abuse, or drug screening positive;
7. Smoking and alcohol addict and unable to stop smoking during the test period; those with positive alcohol screening; those with positive nicotine screening;
8. Subjects who have swallowing resistance or obstacle that will affect the drug absorption;
9. Allergic constitution, including severe drug allergy or drug allergy history; known allergy to fluconazole and famitinib or its excipients;
10. Those who have participated in other clinical trials and taken the study drug within 3 months before taking the study drug for the first time;
11. Inducers or inhibitors of CYP3A4 were taken within 4 weeks before the first administration of study drug;
12. Taking any prescription drug, over-the-counter drug, traditional Chinese medicine or food supplement within 2 weeks before taking the study drug for the first time;
13. Ingestion of grapefruit containing products, fruit juice, food or beverage containing methylxanthine or alcohol within 48 hours before taking the study drug for the first time; taking strenuous exercise; or having other factors affecting the absorption, distribution, metabolism and excretion of drugs;
14. Lactating women;
15. The researchers considered that the subjects had any other factors that were not suitable for the trial.

Primary outcomes:
measure: Maximum observed serum concentration (Cmax) for famitinib
timeFrame: Day 1 to Day 25
measure: Area under the concentration-time curve from time zero to time t (AUC0-t,) for famitinib
timeFrame: Day 1 to Day 25
measure: Area under the concentration-time curve extrapolated to infinity (AUC0-∞.) for famitinib (if applicable)
timeFrame: Day 1 to Day 25
Secondary outcomes:
measure: Time to maximum observed serum concentration (Tmax) for famitinib
timeFrame: Day 1 to Day 25
measure: Time to elimination half-life (t1/2) for famitinib
timeFrame: Day 1 to Day 25
measure: Apparent oral clearance (CL/F) for famitinib
timeFrame: Day 1 to Day 25
measure: Apparent Volume of Distribution (Vz/F) for famitinib
timeFrame: Day 1 to Day 25
measure: Tmax for famitinib metabolite SHR116637
timeFrame: Day 1 to Day 25
measure: Cmax for famitinib metabolite SHR116637
timeFrame: Day 1 to Day 25
measure: AUC0-t, for famitinib metabolite SHR116637
timeFrame: Day 1 to Day 25
measure: AUC0-∞. for famitinib metabolite SHR116637(if applicable)
timeFrame: Day 1 to Day 25
measure: t1/2 for famitinib metabolite SHR116637
timeFrame: Day 1 to Day 25
measure: The incidence and severity of adverse events/serious adverse events (based on NCI-CTC AE 5.0)
timeFrame: Day 1 to Day 25
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: