A Food Effect Study of KC1036 in Healthy Subjects

Beijing Konruns Pharmaceutical

Status

Completed

Conditions

Healthy Subjects

Treatments

Drug: KC1036

Study type

Interventional

Funder types

Industry

Identifiers

NCT05265338

KC1036-I-02

Details and patient eligibility

About

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.

Full 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).

Enrollment

12 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.