Healthy SubjectsPhase 1NCT05069870
A Study to Investigate the Drug-drug Interactions (DDIs) of SKLB1028 With Itraconazole, Gemfibrozil or Rifampicin in Healthy Subjects
A Phase 1 study testing SKLB1028, Itraconazole and Gemfibrozil in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a three-part, single-center, open-label phase I clinical study to characterize the DDIs potential of SKLB1028 with Itraconazole, Gemfibrozil or Rifampicin in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Itraconazole, Gemfibrozil or Rifampicin. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- SKLB1028, Itraconazole and Gemfibrozil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2021to Nov 2021
- Phase
- Phase 1
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- Healthy subjects:
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- 18 ≤ age ≤45, male;
- Subjects with weight ≥50.0 kg and body mass index (BMI) 19-26 kg/m^2 (inclusive);
- Subjects are willing to use effective contraceptives and not allowed to donate sperm from screening to the 6 months after the last dose administration unless permanent contraception has been taken, such as vasectomy.
- Ability to communicate well with researchers, and be willing to comply with all trial requirements.
Who cannot join
- Allergic constitution, including a history of allergy to any of the study drugs or other similarly structured drugs;
- Previous or current severe diseases, such as cardiovascular, respiratory, gastrointestinal, endocrine, hematological, psychiatric/neurological systems diseases, or any other disease that can interfere with the results of the study;
- Subjects who have previously undergone surgery that may affect the absorption, distribution, metabolism, or excretion of the drug (e.g., subtotal gastrectomy), or who have a scheduled surgical plan during the study period;
- Use of any strong inhibitors or inducers of CYP3A4, CYP2C8 or P-gp within 2 weeks prior to screening;
- Use of any prescription drug, over-the-counter drug, herbal medicine or health products within 2 weeks prior to screening;
- History of drug abuse within 1 year prior to screening, or positive urine drug screen at screening;
Show all 16Show fewer
- Smoking more than 5 cigarettes per day within 6 months prior to screening;
- Average daily intake of alcohol more than 14 units (14 units ≈285 mL of beer, or 25 mL of liquor, or 150 mL of wine) within 4 weeks prior to screening, or a positive ethanol breath test at screening;
- Consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) within 48 h before the administration, or those who have had strenuous exercise, or have other factors affecting absorption, distribution, metabolism, excretion, etc of the drug;
- Participation in another clinical trial within 3 months before screening (whichever is administrated);
- Blood donation (or blood loss) ≥200 mL within 4 weeks prior to the screening, or who have a blood donation plan during the entire study or within 1 months after the study;
- Any abnormalities of clinical significance in physical examination, vital signs, clinical laboratory tests (routine blood test, blood biochemistry, routine urine test, coagulation function), anteroposterior chest radiograph or chest CT scan;
- Abnormalities of clinical significance in 12-lead ECG examination (such as tachycardia/bradycardia in need of medical treatment, II-III degree atrioventricular block, QTcF>450 ms or any other clinically significant abnormalities );
- Any positive test result of hepatitis B surface antigen or hepatitis C virus antibody, or subjects with a history of hepatitis B;
- Any positive test result of anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
- Any condition that, in the opinion of the Investigator, may prevent the subject from completing the study or poses a significant risk to the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-part, Single-center, Open-label, Phase I Drug-drug Interaction Clinical Study to Investigate the Effect of Itraconazole, Gemfibrozil or Rifampicin on Pharmacokinetics of SKLB1028 in Healthy Subjects
This is a three-part, single-center, open-label phase I clinical study to characterize the DDIs potential of SKLB1028 with Itraconazole, Gemfibrozil or Rifampicin in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Itraconazole, Gemfibrozil or Rifampicin.
Read the detailed description
SKLB1028 is the potential substrate of CYP3A4, CYP2C8 and P-gp. This study conducted in three parts to characterize the DDIs potential of SKLB1028 with the perpetrator drugs ( Itraconazole, Gemfibrozil, Rifampicin) in Healthy Subjects. Each part of this study consists of a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period.
- Conditions
- Healthy Subjects
- Being tested
- SKLB1028, Itraconazole, Gemfibrozil, Rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKLB1028Drug
SKLB1028, capsule, oral
ItraconazoleDrug
Itraconazole, capsule, oral
GemfibrozilDrug
Gemfibrozil, capsule, oral
RifampicinDrug
Rifampicin, capsule, oral
| Study group | Role | What they receive |
|---|---|---|
| The DDI of SKLB1028 and Itraconazole | Experimental | Eligible subjects received a single dose of SKLB1028 100 mg on Day 1, then took Itraconazole 200 mg twice-daily on Day 8 and 200 mg once-daily on Day 9 through Day 18, and took a single dose of SKLB1028 100 mg on Day 11. Receives: Drug: SKLB1028; Drug: Itraconazole |
| The DDI of SKLB1028 and Gemfibrozil | Experimental | Eligible subjects received a single dose of SKLB1028 100 mg on Day 1, then took Gemfibrozil 600 mg twice-daily on Day 8 through Day 19, and took a single dose of SKLB1028 100 mg on Day 12. Receives: Drug: SKLB1028; Drug: Gemfibrozil |
| The DDI of SKLB1028 and Rifampicin | Experimental | Eligible subjects received a single dose of SKLB1028 150 mg on Day 1, then took Rifampicin 600 mg once-daily on Day 8 through Day22, and took a single dose of SKLB1028 150 mg on Day 15. Receives: Drug: SKLB1028; Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of SKLB1028
Measured: Up to 22 days
Area under the concentration-time curve (AUC) from 0 to the last measurable concentration (AUC0-t) of SKLB1028
Measured: Up to 22 days
AUC extrapolated to infinity (AUCinf) of SKLB1028
Measured: Up to 22 days
Secondary outcomes (23)
Time to Cmax (Tmax) of SKLB1028
Measured: Up to 22 days
Terminal elimination half-life (t1/2) of SKLB1028
Measured: Up to 22 days
Apparent Clearance (CLz/F) of SKLB1028
Measured: Up to 22 days
Apparent volume of distribution (Vz/F) of SKLB1028
Measured: Up to 22 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Up to approximately 30 days
Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.
Routine blood test included cell count (white blood cells, platelets, basophils, eosinophils, neutrophils, lymphocytes and monocytes) in 10^9/L.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.
Routine blood test included red blood cell count in 10^12/L.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.
Routine blood test included hemoglobin in g/L.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Blood biochemistry test included total bilirubin and serum creatinine in μmol/L.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Blood biochemistry test included alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and creatine kinase in U/L.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Blood biochemistry test included total protein and albumin in g/L.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Blood biochemistry test included total cholesterol, triglyceride and blood glucose in mmol/L.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in routine urine test were recorded as AEs at each visit time point.
Routine urine test included protein, urobilinogen, glucose and ketones (positive or negative).
Measured: Up to approximately 30 days
Clinically significant changes from baseline in routine urine test were recorded as AEs at each visit time point.
Routine urine test included pH value and specific gravity.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.
Coagulation function test included prothrombin time and activated partial thromboplastin time in seconds.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.
Coagulation function test included antithrombin III as percentage.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.
Coagulation function test included fibrinogen in g/L.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination were recorded as AEs at each visit time point.
ECG monitoring included heart rate in bpm.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination were recorded as AEs at each visit time point.
ECG monitoring included P-R, QRS, QT and QTcF in ms.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.
Vital signs monitoring included body temperature in degrees Celsius.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.
Vital signs monitoring included respiratory rate and pulse in times per minute.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.
Vital signs monitoring included systolic blood pressure and diastolic blood pressure in mmHg.
Measured: Up to approximately 30 days
Clinically significant changes from baseline in physical examination were recorded as AEs at each visit time point.
Physical examination included general conditions, skin, mucous membranes, head, neck, chest, abdomen, spine, limbs, nervous system, and lymphatic system.
Measured: Up to approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start7 Jun 2021
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
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.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069870
- Sponsor's protocol ID
- HA114-CSP-009
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-part, Single-center, Open-label, Phase I Drug-drug Interaction Clinical Study to Investigate the Effect of Itraconazole, Gemfibrozil or Rifampicin on Pharmacokinetics of SKLB1028 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05069870
- Acronym / sponsor ID
- HA114-CSP-009
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 6 Oct 2021 (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.
This is a three-part, single-center, open-label phase I clinical study to characterize the DDIs potential of SKLB1028 with Itraconazole, Gemfibrozil or Rifampicin in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Itraconazole, Gemfibrozil or Rifampicin.
Detailed description
SKLB1028 is the potential substrate of CYP3A4, CYP2C8 and P-gp. This study conducted in three parts to characterize the DDIs potential of SKLB1028 with the perpetrator drugs ( Itraconazole, Gemfibrozil, Rifampicin) in Healthy Subjects. Each part of this study consists of a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The DDI of SKLB1028 and Itraconazole | Experimental | Drug: SKLB1028, Drug: ItraconazoleEligible subjects received a single dose of SKLB1028 100 mg on Day 1, then took Itraconazole 200 mg twice-daily on Day 8 and 200 mg once-daily on Day 9 through Day 18, and took a single dose of SKLB1028 100 mg on Day 11. |
| The DDI of SKLB1028 and Gemfibrozil | Experimental | Drug: SKLB1028, Drug: GemfibrozilEligible subjects received a single dose of SKLB1028 100 mg on Day 1, then took Gemfibrozil 600 mg twice-daily on Day 8 through Day 19, and took a single dose of SKLB1028 100 mg on Day 12. |
| The DDI of SKLB1028 and Rifampicin | Experimental | Drug: SKLB1028, Drug: RifampicinEligible subjects received a single dose of SKLB1028 150 mg on Day 1, then took Rifampicin 600 mg once-daily on Day 8 through Day22, and took a single dose of SKLB1028 150 mg on Day 15. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- -
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- 18 ≤ age ≤45, male;
- Subjects with weight ≥50.0 kg and body mass index (BMI) 19-26 kg/m^2 (inclusive);
- Subjects are willing to use effective contraceptives and not allowed to donate sperm from screening to the 6 months after the last dose administration unless permanent contraception has been taken, such as vasectomy.
Key exclusion criteria (16 listed)
- Allergic constitution, including a history of allergy to any of the study drugs or other similarly structured drugs;
- Previous or current severe diseases, such as cardiovascular, respiratory, gastrointestinal, endocrine, hematological, psychiatric/neurological systems diseases, or any other disease that can interfere with the results of the study;
- Subjects who have previously undergone surgery that may affect the absorption, distribution, metabolism, or excretion of the drug (e.g., subtotal gastrectomy), or who have a scheduled surgical plan during the study period;
- Use of any strong inhibitors or inducers of CYP3A4, CYP2C8 or P-gp within 2 weeks prior to screening;
- Use of any prescription drug, over-the-counter drug, herbal medicine or health products within 2 weeks prior to screening;
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 |
|---|---|---|
| SKLB1028SKLB1028, capsule, oral | Drug | The DDI of SKLB1028 and Gemfibrozil, The DDI of SKLB1028 and Itraconazole, The DDI of SKLB1028 and Rifampicin |
| ItraconazoleItraconazole, capsule, oral | Drug | The DDI of SKLB1028 and Itraconazole |
| GemfibrozilGemfibrozil, capsule, oral | Drug | The DDI of SKLB1028 and Gemfibrozil |
| RifampicinRifampicin, capsule, oral | Drug | The DDI of SKLB1028 and Rifampicin |
Primary outcome
Maximum concentration (Cmax) of SKLB1028
Time frame: Up to 22 days
Area under the concentration-time curve (AUC) from 0 to the last measurable concentration (AUC0-t) of SKLB1028
Time frame: Up to 22 days
AUC extrapolated to infinity (AUCinf) of SKLB1028
Time frame: Up to 22 days
23 secondary outcomes
Time to Cmax (Tmax) of SKLB1028
Time frame: Up to 22 days
Terminal elimination half-life (t1/2) of SKLB1028
Time frame: Up to 22 days
Apparent Clearance (CLz/F) of SKLB1028
Time frame: Up to 22 days
Apparent volume of distribution (Vz/F) of SKLB1028
Time frame: Up to 22 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in routine urine test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in routine urine test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Clinically significant changes from baseline in physical examination were recorded as AEs at each visit time point.
Time frame: Up to approximately 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
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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 Phase 1 study testing SKLB1028, Itraconazole and Gemfibrozil in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology 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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 6 Oct 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Maximum concentration (Cmax) of SKLB1028 (time frame: Up to 22 days). The study lists 3 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 6 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.