A Food Effect Study of KC1036 in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: KC1036

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).

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: KC1036; 60mg QD
Experimental: 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).	Drug: KC1036; 60mg QD

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): March 23, 2022
• Study Completion (Actual): March 23, 2022

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KC1036-I-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No