A Food Effect Study of KC1036 in Healthy Subjects

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Phase I Study of KC1036 on Pharmacokinetics to Assess the Effect of High Fat Diet in Chinese Adult Healthy Subjects.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: KC1036


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double cycle, self crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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). | Drug: KC1036<br>* 60mg QD<br>|
| Experimental: Group B<br>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). | Drug: KC1036<br>* 60mg QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) profile: Cmax | Peak Plasma Concentration | up to 13 Days | 
| Pharmacokinetics (PK) profile: Tmax | Time to reach the maximum plasma concentration | up to 13 Days | 
| Pharmacokinetics (PK) profile: T1/2 | Terminal half-life | up to 13 Days | 
| Pharmacokinetics (PK) profile: AUC | Area under the single-dose plasma concentration-time curve | up to 13 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| material balance | Drug recovery | up to 13 Days | 
| Adverse events (AEs) | Incidence of treatment-related AEs | up to 43 Days |