A Food Effect Study of KC1036 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05265338
• Other study ID #: KC1036-I-02
• Status: Completed
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: March 23, 2022

Study information

• Verified date: October 2023
• Source: Beijing Konruns Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 23, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• KC1036
60mg QD

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Konruns Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) profile: Cmax	Peak Plasma Concentration	up to 13 Days
Primary	Pharmacokinetics (PK) profile: Tmax	Time to reach the maximum plasma concentration	up to 13 Days
Primary	Pharmacokinetics (PK) profile: T1/2	Terminal half-life	up to 13 Days
Primary	Pharmacokinetics (PK) profile: AUC	Area under the single-dose plasma concentration-time curve	up to 13 Days
Secondary	material balance	Drug recovery	up to 13 Days
Secondary	Adverse events (AEs)	Incidence of treatment-related AEs	up to 43 Days