A Study to Investigate the Drug-drug Interactions (DDIs) Between SKLB1028 and Midazolam in Healthy Subjects

NCT ID: NCT05070195

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2021-07-09

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The DDI of SKLB1028 and Midazolam

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.

Group Type: EXPERIMENTAL

SKLB1028

Intervention Type: DRUG

SKLB1028, capsule, oral

Midazolam

Intervention Type: DRUG

Midazolam Maleate, tablet, oral

Interventions

SKLB1028

SKLB1028, capsule, oral

Intervention Type: DRUG

Midazolam

Midazolam Maleate, tablet, oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

Healthy subjects:

1. Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;

2. 18 ≤ age ≤45, male;

3. Subjects with weight ≥50.0 kg and body mass index (BMI) 19-26 kg/m^2 (inclusive);

4. 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;

5. Ability to communicate well with researchers, and be willing to comply with all trial requirements.

Exclusion Criteria

1. Allergic constitution, including a history of allergy to any of the study drugs or other similarly structured drugs;

2. 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;

3. Subjects with sleep apnea syndrome;

4. Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;

5. Subjects with acute angle closure glaucoma;

6. 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;

7. 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;

8. Use of any prescription drug, over-the-counter drug, herbal medicine or health products within 2 weeks prior to screening;

9. History of drug abuse within 1 year prior to screening, or positive urine drug screen at screening;

10. Smoking more than 5 cigarettes per day within 6 months prior to screening;

11. 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;

12. 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;

13. Subjects who have received vaccinations within 4 weeks prior to screening;

14. Participation in another clinical trial within 3 months before screening (whichever is administrated);

15. 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;

16. 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;

17. 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);

18. Any positive test result of hepatitis B surface antigen or hepatitis C virus antibody, or subjects with a history of hepatitis B;

19. Any positive test result of anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;

20. Subjects with a history of fainting needle or blood, cannot tolerate vein puncture for blood collection;

21. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

HA114-CSP-011

Identifier Type: -

Identifier Source: org_study_id