Healthy SubjectsPhase 1NCT05070195
A Study to Investigate the Drug-drug Interactions (DDIs) Between SKLB1028 and Midazolam in Healthy Subjects
A Phase 1 study testing SKLB1028 and Midazolam in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, open-label phase I clinical study to investigate the effect of SKLB1028 on the pharmacokinetics of Midazolam and its metabolite 1'-OH-midazolam in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Midazolam. 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 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2021to 9 Jul 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 non-hormonal contraceptives such as sexual abstinence, 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 with sleep apnea syndrome;
- Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
- Subjects with acute angle closure glaucoma;
- 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;
Show all 21Show fewer
- Use of any inhibitors or inducers of CYP3A4, or any strong inhibitors or inducers of 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;
- 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;
- Subjects who have received vaccinations within 4 weeks prior to screening;
- 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;
- Subjects with a history of fainting needle or blood, cannot tolerate vein puncture for blood collection;
- Any condition that, in the opinion of the Investigator, may prevent the subject from completing the study or pose a significant risk to the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Phase I Drug-drug Interaction Clinical Study to Investigate the Effect of SKLB1028 on the Pharmacokinetics of Midazolam in Healthy Subjects
This is a single-center, open-label phase I clinical study to investigate the effect of SKLB1028 on the pharmacokinetics of Midazolam and its metabolite 1'-OH-midazolam in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Midazolam.
Read the detailed description
This study aims to characterize the drug-drug Interactions (DDI) potential of SKLB1028 with the sensitive index substrate drug (Midazolam) in Healthy Subjects. The 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, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKLB1028Drug
SKLB1028, capsule, oral
MidazolamDrug
Midazolam Maleate, tablet, oral
| Study group | Role | What they receive |
|---|---|---|
| The DDI of SKLB1028 and Midazolam | Experimental | Eligible subjects received a single dose of Midazolam 15 mg on Day 1, and took a single dose of Midazolam 15 mg and a single dose of SKLB1028 150 mg with dosing interval of 0.5 h on Day 3. Receives: Drug: SKLB1028; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)of Midazolam and its metabolite 1'-OH-midazolam
Measured: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Area under the concentration-time curve (AUC) from 0 to the last measurable concentration (AUC0-t) of Midazolam and its metabolite 1'-OH-midazolam
Measured: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
AUC extrapolated to infinity (AUCinf) of Midazolam and its metabolite 1'-OH-midazolam
Measured: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Secondary outcomes (23)
Time to Cmax (Tmax) of Midazolam and its metabolite 1'-OH-midazolam
Measured: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Terminal elimination half-life (t1/2) of Midazolam and its metabolite 1'-OH-midazolam
Measured: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Apparent Clearance (CLz/F) of Midazolam
Measured: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Apparent volume of distribution (Vz/F) of Midazolam
Measured: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in routine urine test were recorded as AEs at each visit time point.
Routine urine test included urobilinogen, protein, glucose and ketones (positive or negative).
Measured: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 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: Throughout the study period, with an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start7 Jun 2021
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT05070195
- Sponsor's protocol ID
- HA114-CSP-011
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 7 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 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Phase I Drug-drug Interaction Clinical Study to Investigate the Effect of SKLB1028 on the Pharmacokinetics of Midazolam in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05070195
- Acronym / sponsor ID
- HA114-CSP-011
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 7 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 single-center, open-label phase I clinical study to investigate the effect of SKLB1028 on the pharmacokinetics of Midazolam and its metabolite 1'-OH-midazolam in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Midazolam.
Detailed description
This study aims to characterize the drug-drug Interactions (DDI) potential of SKLB1028 with the sensitive index substrate drug (Midazolam) in Healthy Subjects. The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The DDI of SKLB1028 and Midazolam | Experimental | Drug: SKLB1028, Drug: MidazolamEligible subjects received a single dose of Midazolam 15 mg on Day 1, and took a single dose of Midazolam 15 mg and a single dose of SKLB1028 150 mg with dosing interval of 0.5 h on Day 3. |
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 non-hormonal contraceptives such as sexual abstinence, 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 (21 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 with sleep apnea syndrome;
- Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
- Subjects with acute angle closure glaucoma;
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 Midazolam |
| MidazolamMidazolam Maleate, tablet, oral | Drug | The DDI of SKLB1028 and Midazolam |
Primary outcome
Maximum concentration (Cmax)of Midazolam and its metabolite 1'-OH-midazolam
Time frame: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Area under the concentration-time curve (AUC) from 0 to the last measurable concentration (AUC0-t) of Midazolam and its metabolite 1'-OH-midazolam
Time frame: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
AUC extrapolated to infinity (AUCinf) of Midazolam and its metabolite 1'-OH-midazolam
Time frame: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
23 secondary outcomes
Time to Cmax (Tmax) of Midazolam and its metabolite 1'-OH-midazolam
Time frame: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Terminal elimination half-life (t1/2) of Midazolam and its metabolite 1'-OH-midazolam
Time frame: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Apparent Clearance (CLz/F) of Midazolam
Time frame: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Apparent volume of distribution (Vz/F) of Midazolam
Time frame: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in routine urine test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in routine urine test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 days
Clinically significant changes from baseline in physical examination were recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 10 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 7 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 and Midazolam 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 21 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 7 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?
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?
Maximum concentration (Cmax)of Midazolam and its metabolite 1'-OH-midazolam (time frame: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)). 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 7 Oct 2021.