A Food Effect Study of KC1036 in Healthy Subjects
- Registration Number
- NCT05265338
- Lead Sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.
- Brief Summary
The primary objective of the study was to assess the effect of High Fat Diet on the pharmacokinetics of KC1036 in Chinese adult healthy subjects.
- Detailed Description
This is an open-label, randomized, two cycle self crossover experimental design study to assess the effect of High Fat Diet on the pharmacokinetics, material balance, safety of KC1036 in Chinese adult healthy subjects. This study was divided into two Groups A and B.
Group A：In the fasting state, KC1036 po only once (60mg QD) and after 7 days, in the high fat diet state, KC1036 po only once (60mg QD).
Group B：In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the fasting state, KC1036 po only once (60mg QD).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
- 18~65 years of age, male.
- The weight of male subject ≥50kg, 19≤BMI≤26g/m2.
- Agree to take adequate contraceptive measures to prevent spouse pregnancy during the clinical trail.
- Able to comprehend and willing to sign an informed consent form (ICF).
- Diseases such as liver, kidney, endocrine, cardiovascular, respiratory, nervous, mental, digestive tract, lung, immunity, skin, blood or metabolic disorders that are considered clinically significant by investigator, or have a history of these diseases, or have undergone major surgery, or factors that will endanger the safety of the subject or affect the research results.
- Physical examination, vital signs, laboratory examination, 12-ECG and chest film are clinically significant.
- Excessive smoking within 3 months before screening.
- History of drug and food allergy.
- Drinking 14 units of alcohol per week within 6 months prior dosing (1 unit = 360 mL of beer, or 150mL of wine).
- Participate in blood donate blood volume≥200mL or blood loss ≥200mL within 3 month prior dosing.
- Take any prescription, any over-the-counter medication, traditional Chinese medicines, vitamin products within14 days prior dosing.
- Take any clinical trial drugs within 3 months prior dosing.
- Dysphagia or history of gastrointestinal diseases affecting drug absorption.
- Combined with other viral infections (anti-HCV, anti-HIV positive, anti-TP positive, HBsAg positive) or combined with syphilis infection.
- Acute diseases requiring clinical treatment before screening or prior dosing.
- Anyone who refuse to stop ingest foods or drinks containing caffeine, alcohol from 48 hours before dosing to the end of the study.
- Urine drug positive or drug users within 3 months prior dosing.
- The investigator believes that the subjects are not eligible to participate in this trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A KC1036 In the fasting state, KC1036 po only once (60mg QD) and after 7 days，in the high fat diet state，KC1036 po only once (60mg QD). Group B KC1036 In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the fasting state, KC1036 po only once (60mg QD).
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK) profile: T1/2 up to 13 Days Terminal half-life
Pharmacokinetics (PK) profile: Cmax up to 13 Days Peak Plasma Concentration
Pharmacokinetics (PK) profile: Tmax up to 13 Days Time to reach the maximum plasma concentration
Pharmacokinetics (PK) profile: AUC up to 13 Days Area under the single-dose plasma concentration-time curve
- Secondary Outcome Measures
Name Time Method Adverse events (AEs) up to 43 Days Incidence of treatment-related AEs
material balance up to 13 Days Drug recovery
Trial Locations
- Locations (1)
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China