A Drug-drug Interaction Trial to Evaluate the Pharmacokinetics Effect of Rifampicin on Famitinib

Study Overview
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Brief Summary
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The primary objective of the study was to assess the effect of repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib. The secondary objective of the study was to assess the safety of Famitinib given alone versus Famitinib co-administered with Rifampicin.

Official Title
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A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Rifampicin on Famitinib in Healthy Male Subjects

Conditions
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Healthy Adult Subjects

Intervention / Treatment
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* Drug: Famitinib capsule
* Drug: Rifampicin capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects aged 18 to 50 years old at the date of signing the informed consent; Male body weight ≥ 50kg, body mass index (BMI) within the range of 19   28 kg/m2 (including 19 and 28) (BMI= weight (kg)/height 2 (m2)); Subjects have no childbirth plans and agree to take effective contraceptive measures within 3 months of the last medication; The subject can communicate well with the researcher, understand and comply with the requirements of the study, understand and sign the informed consent. Exclusion Criteria: History of or currently suffering from any serious clinical diseases such as diseases in circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases may interfere with the test results; Any surgery within 6 months before screening, or plan to perform surgery during the study period, or who have previously undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, gastric reduction surgery, etc.) Blood donation or massive blood loss (≥200 mL), or received blood transfusion, or used blood products within 3 months before screening; History of allergy to drugs, food or other substances; Frequent use of sedatives, sleeping pills or other addictive drugs; History of drug abuse within 1 year prior to screening; Positive for urine drug abuse screening test; Participated in any clinical trial and took the study drug within 3 months prior to the first administration; Used any prescription drug or herbal tonic within 1 month before the first administration; Have used any over-the-counter (OTC) medicines, food supplements (including vitamins, calcium tablets, etc.) within 2 weeks prior to the first administration; Those who had smoked more than 5 cigarettes per day in the previous 3 months before screening and could not stop using any tobacco products during the study period; Nicotinic test positive; Frequent drinkers in the previous 6 months before screening, i.e., those who drink more than 14 units of alcohol per week (1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine) and cannot stop using any alcoholic products during the study period; alcohol test positive; Abnormal vital signs, physical examination, 12-lead ECG, abdominal B-ultrasound, chest radiograph, routine blood test, biochemical test, routine urine test and blood coagulation test with clinical significance; Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive; Subjects have taken and do not agree to stop using any drink or food containing methylxanthine, such as coffee, tea, cola, chocolate, etc. from 48 hours before the first administration until end of the study;, subjects have taken and do not agree to discontinue any beverage or food containing grapefruit from 7 days prior to initial administration until end of the study; Those who have special requirements on diet and cannot follow a uniform diet; Subjects who are considered to have other factors that are not appropriate to participate in this study by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>single dose of Famitinib on Day 1, and co-administered with Rifampicin on Day 16 | Drug: Famitinib capsule<br>* single dose and co-administrated with Rifampicin capsule<br>* Other names: SHR1020;Drug: Rifampicin capsule<br>* repeated doses of Rifampicin capsule<br>* Other names: Rifampicin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 | 
| AUC0-t of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 | 
| AUCinf of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 | 
| T1/2 of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 | 
| CL/F of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 | 
| Vz/F of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 | 
| incidence of adverse events/serious adverse events | safety evaluation based on NCI-CTC AE 5.0 | from ICF signing date to approximate Day 31 |