- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05041920
A Drug-drug Interaction Study of Famitinib Malate With a Proton Pump Inhibitor in Healthy Adult Subjects
May 22, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Single-centre, Single-arm, Open-label and Fixed-sequence Study to Evaluate the Effect of Omeprazole on Pharmacokinetics of Famitinib Malate in Healthy Adult Subjects
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Zhongda Hospital, Affiliated to Southest University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Consumption of grapefruit or grapefruit products, caffeine, or xanthine foods or beverages within 48 hours prior to taking the investigational drug; Strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
- Lactating women;
- History of injection needle or blood fainting, those who have difficulty in blood collection or cannot tolerate venepuncture blood collection; Those who cannot accept a uniform diet;
- Subjects with other factors unsuitable to participate in the study considered by the researcher or subjects withdraw from the study due to their own reasons.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm
The study will have only one study group in a fixed-sequence type of design.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax
Time Frame: day 1 to day 23
|
day 1 to day 23
|
AUC0-t
Time Frame: day 1 to day 23
|
day 1 to day 23
|
AUC0-∞(if applicable)
Time Frame: day 1 to day 23
|
day 1 to day 23
|
Tmax
Time Frame: day 1 to day 23
|
day 1 to day 23
|
t1/2
Time Frame: day 1 to day 23
|
day 1 to day 23
|
CL/F
Time Frame: day 1 to day 23
|
day 1 to day 23
|
Vz/F
Time Frame: day 1 to day 23
|
day 1 to day 23
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence and severity of adverse events/serious adverse events
Time Frame: from ICF signing date to approximate day 30
|
from ICF signing date to approximate day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2021
Primary Completion (Actual)
October 6, 2021
Study Completion (Actual)
October 27, 2021
Study Registration Dates
First Submitted
September 3, 2021
First Submitted That Met QC Criteria
September 3, 2021
First Posted (Actual)
September 13, 2021
Study Record Updates
Last Update Posted (Actual)
May 24, 2023
Last Update Submitted That Met QC Criteria
May 22, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMTN-I-111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tumor
-
Sorrento Therapeutics, Inc.WithdrawnSolid Tumor | Relapsed Solid Tumor | Refractory Tumor
-
Aadi Bioscience, Inc.RecruitingAdvanced Solid Tumor | Tumor | Tumor, SolidUnited States
-
Yonsei UniversityMerck KGaA, Darmstadt, GermanyActive, not recruitingPD-L1 Positive Mutation Tumor | EBV Positive Mutation Tumor | MSI-H Mutation Tumor | POLE/POLD1 Mutation TumorKorea, Republic of
-
Memorial Sloan Kettering Cancer CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States, Puerto Rico
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States, Puerto Rico
-
RemeGen Co., Ltd.CompletedMetastatic Solid Tumor | Locally Advanced Solid Tumor | Unresectable Solid TumorAustralia
-
National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalRecruiting
-
Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.RecruitingNeoplasms | Solid Tumor | Malignant TumorChina
-
Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyRecruitingSolid Tumor, Adult | Refractory TumorUnited States
Clinical Trials on famitinib、omeprazole
-
Jiangsu HengRui Medicine Co., Ltd.CompletedColorectal Cancer Metastatic | Colorectal Cancer RecurrentChina
-
Jiangsu HengRui Medicine Co., Ltd.Sun Yat-sen University; Shanghai Pulmonary Hospital, Shanghai, ChinaSuspendedNon-Small Cell Lung Cancer (NSCLC)China
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingRenal Cell Carcinoma | Cervical Cancer | Endometrial Cancer | Urothelial Carcinoma | Ovarian Cancer RecurrentChina
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.Sun Yat-sen UniversityCompletedRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal CarcinomaChina
-
Jiangsu HengRui Medicine Co., Ltd.UnknownGastrointestinal Stromal TumorChina
-
Shanghai Chest HospitalNot yet recruiting
-
Jiangsu HengRui Medicine Co., Ltd.CompletedHealthy Adult SubjectsChina
-
Jiangsu HengRui Medicine Co., Ltd.Active, not recruitingHealthy SubjectsChina
-
Jiangsu HengRui Medicine Co., Ltd.Cancer Institute and Hospital, Chinese Academy of Medical SciencesTerminatedGastroenteropancreatic Neuroendocrine TumorChina