A Food Effect Study of KC1036 in Healthy Subjects

NCT05265338 | Completed

• 1 other identifier: KC1036-I-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• material balance

  up to 13 Days

• Adverse events (AEs)

  up to 43 Days

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

KC1036 DRUG

60mg QD

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Konruns Pharmaceutical Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double cycle, self crossover

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 3, 2022
• Study Start: March 10, 2022
• Primary Completion: March 23, 2022
• Study Completion: March 23, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)