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

Healthy Adult Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494659
• Other study ID #: FMTN-I-105
• Status: Completed
• Phase: Phase 1
• Start date: July 20, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: July 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 31, 2020
• Est. primary completion date: August 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Healthy male subjects aged 18 to 50 years old at the date of signing the informed consent;

2. 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));

3. Subjects have no childbirth plans and agree to take effective contraceptive measures within 3 months of the last medication;

4. 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:

1. 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;

2. 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.)

3. Blood donation or massive blood loss (=200 mL), or received blood transfusion, or used blood products within 3 months before screening;

4. History of allergy to drugs, food or other substances;

5. 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;

6. Participated in any clinical trial and took the study drug within 3 months prior to the first administration;

7. 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;

8. 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;

9. 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;

10. 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;

11. Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive;

12. 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;

13. Subjects who are considered to have other factors that are not appropriate to participate in this study by the investigator.

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• Famitinib capsule
single dose and co-administrated with Rifampicin capsule
• Rifampicin capsule
repeated doses of Rifampicin capsule

Locations

Country	Name	City	State
China	Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Famitinib	Pharmacokinetics parameters of Famitinib	Day 1 to Day 24
Primary	AUC0-t of Famitinib	Pharmacokinetics parameters of Famitinib	Day 1 to Day 24
Primary	AUCinf of Famitinib	Pharmacokinetics parameters of Famitinib	Day 1 to Day 24
Secondary	Tmax of Famitinib	Pharmacokinetics parameters of Famitinib	Day 1 to Day 24
Secondary	T1/2 of Famitinib	Pharmacokinetics parameters of Famitinib	Day 1 to Day 24
Secondary	CL/F of Famitinib	Pharmacokinetics parameters of Famitinib	Day 1 to Day 24
Secondary	Vz/F of Famitinib	Pharmacokinetics parameters of Famitinib	Day 1 to Day 24
Secondary	incidence of adverse events/serious adverse events	safety evaluation based on NCI-CTC AE 5.0	from ICF signing date to approximate Day 31