A Food Effect Study of FMTN on Healthy Chinese Adult Subjects

NCT04616716 | Completed Phase 1

• 1 other identifier: FMTN-I-104
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study was to assess the effect of high-fat and low-fat meal on the pharmacokinetics of FMTN in Chinese adult healthy subjects. The secondary objective of the study was to assess the safety of FMTN administered in adult healthy subjects.

Conditions

Health, Subjective

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum Observed Plasma Concentration for FMTN

  Day 1:0-192 hours (h) ;Day10:0-192 h; Day 19:0-19h

• AUC0-t

  Area under the concentration-time curve form 0(pre-dose) to time of last concentration of FMTN

  Day 1:0-192 hours (h);Day 10:0-192 h; Day 19:0-192 h

• AUC0-inf

  Area under the concentration-time curve form 0(pre-dose) to infinite time of FMTN

  Day 1:0-192 hours (h);Day 10:0-192 h; Day 19:0-19 h

Study Arms (6)

1

EXPERIMENTAL

Drug:FMTN fasted in P1,low-fat diet in P2,high-fat diet in P3 FMTN administration in fasted condition in period 1,FMTN administration after low-fat diet in period 2,FMTN administration after high-fat diet in period 3

Drug: FMTN

2

EXPERIMENTAL

Drug:FMTN high-fat diet in P1,fasted in P2,low-fat diet in P3 FMTN administration after high-fat diet in period 1,FMTN administration in fasted condition in period 2,FMTN administration after low-fat diet in period 3

Drug: FMTN

3

EXPERIMENTAL

Drug:FMTN low-fat diet in P1,high-fat diet P2,fasted in P3 FMTN administration after low-fat diet in period 1,FMTN administration after high-fat diet in period 2,FMTN administration in fasted condition in period 3

Drug: FMTN

4

EXPERIMENTAL

Drug:FMTN fasted in P1,high-fat diet P2,low-fat diet in P3 FMTN administration in fasted condition in period 1,FMTN administration after high-fat diet in period 2,FMTN administration after low-fat diet in period 3

Drug: FMTN

5

EXPERIMENTAL

Drug:FMTN low-fat diet in P1,fasted P2,high-fat diet in P3 FMTN administration after low-fat diet in period 1,FMTN administration in fasted condition in period 2,FMTN administration after high-fat diet in period 3

Drug: FMTN

6

EXPERIMENTAL

Drug:FMTN high-fat diet in P1,low-fat diet P2,fasted in P3 FMTN administration after high-fat diet in period 1,FMTN administration after low-fat diet in period 2,FMTN administration in fasted condition in period 3

Drug: FMTN

Interventions

FMTN DRUG

Single dose of FMTN after high-fat meal,low-fat meal and fast

1; 2; 3; 4; 5; 6

Eligibility Criteria

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

You may qualify if:

• Sign informed consent prior to the test, and fully understand the content, process and possible adverse reactions of the test;
• Be able to complete the study according to the requirements of the test plan;
• Healthy male and female subjects aged 18 to 45 years old (including values at both ends) on the day of signing the informed consent, with a ratio of 1:1.
• Subjects have no family planning and take effective contraceptive measures voluntarily from 2 weeks before screening to 6 months after the last medication. Serum HCG test of fertile women must be negative before screening;
• The body weight of male subjects is not less than 50kg, and that of female subjects is not less than 45kg, and the body mass index (BMI) is within the range of 19-28 kg/m2 (including the critical value);

You may not qualify if:

• Abnormalities judged by clinicians as clinically significant, including physical examination, vital signs examination, electrocardiogram or clinical laboratory examination, or a history of serious cardiac, liver, kidney, digestive tract, nervous system, respiratory system, mental and metabolic abnormalities;
• Those who participated in blood donation with blood donation volume ≥400mL within 3 months before taking the first study drug, or those who received blood transfusion;
• Allergic constitution, including a history of severe drug allergy or drug allergy, allergy to malate famitinib capsule or its excipients;
• A history of drug use, drug screening positive or a history of drug abuse in the past five years or drug use in the 3 months prior to the trial;
• A history of heavy drinking (14 units of alcohol per week: 1 unit = 285mL beer, 25mL spirits or 100mL wine);
• Those who smoked more than 5 cigarettes per day in the first 3 months of the study;
• women \> 470 msec or men \>450 msec of QT interval (QTcF) corrected by Fridericia method in 12-lead electrocardiogram;
• Left ventricular ejection fraction (LVEF) \<50% in cardiac color ultrasound;
• Screening those who have received any surgery in the previous 6 months;
• Screening for long-term use of hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicol) within the first 6 months;
• have taken any clinical trial drug within 3 months prior to the first use of the study drug;
• Any drug that alters liver enzyme activity within 4 weeks prior to the first administration of the study drug;
• Any prescription or non-prescription drug, any vitamin product, health care product or herb taken within 2 weeks prior to the first use of the study drug;
• HCV antibody positive, HIV antibody positive, HBsAg positive, syphilis antibody positive;
• Ingestion of grapefruit or products containing grapefruit, caffeine and xanthine foods or beverages within 48 hours prior to taking the study drug;Strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Jinan Central Hospital

Jinan, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 5, 2020
• Study Start: May 6, 2020
• Primary Completion: September 29, 2020
• Study Completion: October 20, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-10

Locations

CN (1)