A Study to Investigate the Drug-drug Interactions (DDIs) of SKLB1028 With Itraconazole, Gemfibrozil or Rifampicin in Healthy Subjects

NCT05069870 | Unknown Phase 1

• 1 other identifier: HA114-CSP-009
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Maximum concentration (Cmax) of SKLB1028

  Up to 22 days

• Area under the concentration-time curve (AUC) from 0 to the last measurable concentration (AUC0-t) of SKLB1028

  Up to 22 days

• AUC extrapolated to infinity (AUCinf) of SKLB1028

  Up to 22 days

Secondary Outcomes (23)

• Time to Cmax (Tmax) of SKLB1028

  Up to 22 days

• Terminal elimination half-life (t1/2) of SKLB1028

  Up to 22 days

• Apparent Clearance (CLz/F) of SKLB1028

  Up to 22 days

• Apparent volume of distribution (Vz/F) of SKLB1028

  Up to 22 days

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Up to approximately 30 days

Study Arms (3)

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.

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.

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.

Drug: SKLB1028; Drug: Rifampicin

Interventions

SKLB1028 DRUG

SKLB1028, capsule, oral

The DDI of SKLB1028 and Gemfibrozil; The DDI of SKLB1028 and Itraconazole; The DDI of SKLB1028 and Rifampicin

Itraconazole DRUG

Itraconazole, capsule, oral

The DDI of SKLB1028 and Itraconazole

Gemfibrozil DRUG

Gemfibrozil, capsule, oral

The DDI of SKLB1028 and Gemfibrozil

Rifampicin DRUG

Rifampicin, capsule, oral

The DDI of SKLB1028 and Rifampicin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects:
• Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
• ≤ 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Interventions

SKLB1028; Itraconazole; Gemfibrozil; Rifampin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 6, 2021
• Study Start: June 7, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-09

Locations

CN (1)