Clinical trial NCT05265338: A Food Effect Study of KC1036 in Healthy Subjects
Official title: A Phase I Study of KC1036 on Pharmacokinetics to Assess the Effect of High Fat Diet in Chinese Adult Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Beijing Konruns Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-03
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double cycle, self crossover
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetics (PK) profile: Cmax
timeFrame: up to 13 Days
measure: Pharmacokinetics (PK) profile: Tmax
timeFrame: up to 13 Days
measure: Pharmacokinetics (PK) profile: T1/2
timeFrame: up to 13 Days
measure: Pharmacokinetics (PK) profile: AUC
timeFrame: up to 13 Days
Secondary outcomes:
measure: material balance
timeFrame: up to 13 Days
measure: Adverse events (AEs)
timeFrame: up to 43 Days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: