Healthy SubjectsNCT05265338
A Food Effect Study of KC1036 in Healthy Subjects
A study testing KC1036 in people with Healthy Subjects, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- KC1036
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2022to 23 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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).
- Conditions
- Healthy Subjects
- Being tested
- KC1036
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KC1036Drug
60mg QD
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: KC1036 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) profile: Cmax
Peak Plasma Concentration
Measured: up to 13 Days
Pharmacokinetics (PK) profile: Tmax
Time to reach the maximum plasma concentration
Measured: up to 13 Days
Pharmacokinetics (PK) profile: T1/2
Terminal half-life
Measured: up to 13 Days
Pharmacokinetics (PK) profile: AUC
Area under the single-dose plasma concentration-time curve
Measured: up to 13 Days
Secondary outcomes (2)
material balance
Drug recovery
Measured: up to 13 Days
Adverse events (AEs)
Incidence of treatment-related AEs
Measured: up to 43 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start10 Mar 2022
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double cycle, self crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265338
- Sponsor's protocol ID
- KC1036-I-02
- Status last verified
- Oct 2023
- First submitted
- 16 Feb 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of KC1036 on Pharmacokinetics to Assess the Effect of High Fat Diet in Chinese Adult Healthy Subjects.
- ClinicalTrials.gov ID
- NCT05265338
- Acronym / sponsor ID
- KC1036-I-02
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Double cycle, self crossover
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: KC1036In 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 | Experimental | Drug: KC1036In 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KC103660mg QD | Drug | Group A, Group B |
Primary outcome
Pharmacokinetics (PK) profile: Cmax
Time frame: up to 13 Days
Peak Plasma Concentration
Pharmacokinetics (PK) profile: Tmax
Time frame: up to 13 Days
Time to reach the maximum plasma concentration
Pharmacokinetics (PK) profile: T1/2
Time frame: up to 13 Days
Terminal half-life
Pharmacokinetics (PK) profile: AUC
Time frame: up to 13 Days
Area under the single-dose plasma concentration-time curve
2 secondary outcomes
material balance
Time frame: up to 13 Days
Adverse events (AEs)
Time frame: up to 43 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KC1036 in people with Healthy Subjects, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) profile: Cmax (time frame: up to 13 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.