A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Design to Evaluate the Pharmacokinetics and Effects on QT Interval of a Single Oral Dose of FCN-437c Capsule in Healthy Subjects.
Overview
- Phase
- Phase 1
- Intervention
- Low dose group
- Conditions
- Advanced Breast Cancer
- Sponsor
- Ahon Pharmaceutical Co., Ltd.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- ΔΔQTcF
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule.
This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control.
This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1．Healthy adult male and female subjects (not less than 1/3 of either sex); 2．18\~45 years old (including boundary values)After bilateral oophorectomy; 3．The body mass index (BMI) should be between 19.0 and 26.0 kg/m2 (including boundary values), and the weight of male subjects should not be less than 50 kg and that of female subjects should not be less than 45 kg; 4．Voluntarily sign informed consent 5．The subjects were able to communicate well with the investigators and complete the test according to protocol.
Exclusion Criteria
- •Patients who meet any of the following conditions are not allowed to enter this clinical study：
- •After a comprehensive physical examination, vital signs, laboratory examination (blood routine, blood biochemistry, coagulation function, urine routine) and other abnormalities and clinical significance;
- •Hyperkalemia, hypokalemia, hypermagnesia, hypomagnesemia, hypercalcemia or hypocalcemia, which is abnormal and clinically significant as determined by the investigator;
- •Abnormal 12-lead ECG results were clinically significant, QTcF≥450 ms, PR interval ≥200 ms;QRS group duration ≥120ms;
- •Hepatitis B surface antigen or hepatitis B core antibody, hepatitis C antibody, HIV antibody or syphilis antibody positive;
- •Any drug that inhibits or induces liver drug metabolism enzymes has been used within 30 days prior to the screening period
- •Use any drug known to prolong the QT interval within 30 days prior to the screening period
- •Use of any prescription, over-the-counter, herbal or food supplements, such as vitamins and calcium supplements, in the 14 days prior to the screening period;
- •A history of any clinically serious medical conditions or conditions that the investigator believes may affect the results of the study, including but not limited to circulatory, respiratory, endocrine, nervous, digestive, urinary, or blood, immune, psychiatric, or metabolic disorders;
- •Have any conditions that may affect drug absorption, such as gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, history of inflammatory bowel;
Arms & Interventions
FCN-437c capsule
fasting oral, single dose.Specification :100mg
Intervention: Low dose group
FCN-437c capsule
fasting oral, single dose.Specification :100mg
Intervention: High dose group
FCN-437c capsule Placebo
fasting oral,single dose.Specification :100mg
Intervention: Low dose group
FCN-437c capsule Placebo
fasting oral,single dose.Specification :100mg
Intervention: High dose group
Outcomes
Primary Outcomes
ΔΔQTcF
Time Frame: 2hours before administration and 48hours and 192hours after administration
The Cmax geometric mean corresponds to the upper 90% bilateral confidence interval of ΔΔQTcF
Secondary Outcomes
- adverse events(Trial period to day 21 after administration)
- Axillary temperature(From 2.0 hours before administration to 21 days after administration)
- blood pressure(From 2.0 hours before administration to 21 days after administration)
- pulse(From 2.0 hours before administration to 21 days after administration)
- Ecg monitoring and electrocardiogram(Trial period to day 21 after administration)
- laboratory examination(Trial period to day 21 after administration)
- Plasma concentration and pharmacokinetic parameters(60 minutes before dosing to day 9 after dosing)
- Physical examination(From 1 day before administration to 21 days after administration)