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Completed

NCT Number: NCT04494659

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266055, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Famitinib capsule

Drug

single dose and co-administrated with Rifampicin capsule

Other names: SHR1020

Rifampicin Capsule

Drug

repeated doses of Rifampicin capsule

Other names: Rifampicin

Primary outcomes

  1. Cmax of Famitinib

    Time frame: Day 1 to Day 24

    Pharmacokinetics parameters of Famitinib

  2. AUC0-t of Famitinib

    Time frame: Day 1 to Day 24

    Pharmacokinetics parameters of Famitinib

  3. AUCinf of Famitinib

    Time frame: Day 1 to Day 24

    Pharmacokinetics parameters of Famitinib

Secondary outcomes

  1. Tmax of Famitinib

    Time frame: Day 1 to Day 24

    Pharmacokinetics parameters of Famitinib

  2. T1/2 of Famitinib

    Time frame: Day 1 to Day 24

    Pharmacokinetics parameters of Famitinib

  3. CL/F of Famitinib

    Time frame: Day 1 to Day 24

    Pharmacokinetics parameters of Famitinib

  4. Vz/F of Famitinib

    Time frame: Day 1 to Day 24

    Pharmacokinetics parameters of Famitinib

  5. incidence of adverse events/serious adverse events

    Time frame: from ICF signing date to approximate Day 31

    safety evaluation based on NCI-CTC AE 5.0

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2020
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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