A Food Effect Study of KC1036 in Healthy Subjects

Sponsor

Beijing Konruns Pharmaceutical Co., Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05265338

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: KC1036	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double cycle, self crossoverDouble cycle, self crossover

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 16, 2022

Anticipated Primary Completion Date :

Aug 16, 2022

Anticipated Study Completion Date :

Feb 16, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

material balance [up to 13 Days]
Drug recovery
Adverse events (AEs) [up to 43 Days]
Incidence of treatment-related AEs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital of Sichuan University	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

Beijing Konruns Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beijing Konruns Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05265338

Other Study ID Numbers:

KC1036-I-02

First Posted:

Mar 3, 2022

Last Update Posted:

Mar 3, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 3, 2022