A Drug-drug Interaction Study of Famitinib Malate With a Proton Pump Inhibitor in Healthy Adult Subjects

NCT05041920 | Completed Phase 1

• 1 other identifier: FMTN-I-111
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the effect of omeprazole on the pharmacokinetics of famitinib malate in healthy adult subjects. The secondary objective is to evaluate the safety after famitinib malate alone or combined administration with omeprazole in healthy adult subjects.

Conditions

Tumor

Outcome Measures

Primary Outcomes (7)

• Cmax

  day 1 to day 23

• AUC0-t

  day 1 to day 23

• AUC0-∞(if applicable)

  day 1 to day 23

• Tmax

  day 1 to day 23

• t1/2

  day 1 to day 23

• CL/F

  day 1 to day 23

• Vz/F

  day 1 to day 23

Secondary Outcomes (1)

• The incidence and severity of adverse events/serious adverse events

  from ICF signing date to approximate day 30

Study Arms (1)

Single arm

EXPERIMENTAL

The study will have only one study group in a fixed-sequence type of design.

Drug: famitinib、omeprazole

Interventions

famitinib、omeprazole DRUG

famitinib malate, 25 mg on study day 1; omeprazole, 40 mg, qd on study day 10-14, 16-22; famotine malate together with omeprazole, on study day 15.

Single arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants should sign the informed consent before the study, and fully understand the content, process and possible adverse reactions of the study;
• Capable to complete the study according to the requirements of study protocol;
• Healthy male and female subjects aged between 18 and 45 (inclusive) at the time of signing the informed consent, of which no less than 1/3 are female subjects;
• Participants should have no fertility plan from signing the informed consent until 6 months after the last medication, take effective contraceptive measures voluntarily and have no sperm donation plan. The serum HCG test of fertile women must be negative before Screening;
• Body weight ≥ 50.0 kg for men and body weight ≥ 45.0 kg for women, and body mass index (BMI) within the range of 19.0 to 28.0 kg /m2 (inclusive);
• Creatinine clearance (CLCr) ≥80 mL/min, and creatinine is less than or equal to the upper limit of normal value.

You may not qualify if:

• Those who donated blood or suffered blood loss ≥400 mL within 3 months prior to Screening, donated blood or suffered blood loss ≥200 mL within 1 month prior to Screening, or received blood transfusion;
• Allergic constitution, including a history of severe drug/food allergy; Any history of allergy to famitinib malate capsules or omeprazole magnesium enteric-coated tablets;
• Any history of drug abuse, positive results for alcohol, nicotine or drugs at Screening;
• Those who have heavy smokers and alcoholic will not be able to prohibit smoking and alcohol during the trial;
• Any history of dysphagia or any gastrointestinal disease that affects drug absorption;
• Those who have any uncontrolled peptic ulcer, colitis, pancreatitis, etc.;
• Those who have received any operation within 6 months before Screening; Previous surgery affecting gastrointestinal absorption (including gastrectomy, intestinal resection, gastric contraction surgery, etc.);
• Subjects with any clinically significant acute disease occurring within 1 month prior to Screening;
• QTcF\>470 msec for women or \>450 msec for men;
• Any pre-existing chronic or severe medical history of nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism, and musculoskeletal system;
• Participation in any clinical trial within 3 months before Screening;
• Those who took any other drugs that affect liver metabolism within 28 days prior to taking the investigational drug;
• Those who took any prescription or non-prescription drugs, any vitamin products or herbal medicine within 14 days prior to receiving the investigational drug;
• Abnormal vital signs at Screening;
• Clinical laboratory tests, infectious disease screening, 12-lead electrocardiogram, abdominal B ultrasound, X-ray or CT examination with abnormalities and clinical significance;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhongda Hospital, Affiliated to Southest University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-arm, open-label and fixed-sequence drug interaction study.

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: September 7, 2021
• Primary Completion: October 6, 2021
• Study Completion: October 27, 2021
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

CN (1)