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CompletedNCT05265338Updated Oct 10, 2023

A Food Effect Study of KC1036 in Healthy Subjects

An interventional study of KC1036 in Healthy Subjects, sponsored by Beijing Konruns Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Beijing Konruns Pharmaceutical Co., Ltd. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study 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.

Read the 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).

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

Beijing Konruns Pharmaceutical Co., Ltd. is the lead sponsor of 13 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugKC1036

    60mg QD

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK) profile: Cmax

    Peak Plasma Concentration

    Time frame: up to 13 Days

  2. Pharmacokinetics (PK) profile: Tmax

    Time to reach the maximum plasma concentration

    Time frame: up to 13 Days

  3. Pharmacokinetics (PK) profile: T1/2

    Terminal half-life

    Time frame: up to 13 Days

  4. Pharmacokinetics (PK) profile: AUC

    Area under the single-dose plasma concentration-time curve

    Time frame: up to 13 Days

Secondary outcomes

  1. material balance

    Drug recovery

    Time frame: up to 13 Days

  2. Adverse events (AEs)

    Incidence of treatment-related AEs

    Time frame: up to 43 Days

07

Study locations

1 site
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05265338
Lead sponsor
Beijing Konruns Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 3, 2022
Start date
Mar 10, 2022
Primary completion
Mar 23, 2022
Completion
Mar 23, 2022
Last update
Oct 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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