A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions

NCT05665283 | Completed Phase 1 FDA Drug

• 1 other identifier: XCV-X396-ONC-103
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, Phase I single dose 2-part, crossover bioequivalence study under fasted conditions. The trial is designed to evaluate the pharmacokinetic parameters between single doses of 100mg ensartinib capsules manufactured by two different processes.

Conditions

Bioequivalency

Keywords

Bioequivalency; Phase I

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum observed concentration

  14 Days

• AUC(0-t)

  Area under the concentration time curve from time 0 to time of the last quantifiable

  14 Days

• AUC(0-∞)

  Area under the concentration time curve from time 0 to infinity

  14 Days

Secondary Outcomes (3)

• tmax

  14 Days

• t1/2

  14 Days

• lz

  14 Days

Study Arms (2)

Reference Standard Group

ACTIVE COMPARATOR

In Period 1, 32 healthy volunteers will divided evenly and randomly assigned to receive 1 dose of 100 mg capsules from either the test product or reference product. In Period 2 the same patients in each cohort will cross over and receive 1 dose of the 100 mg from the other group. These healthy volunteers will receive 1 dose from each of the 100 mg capsules manufactured by both processes.

Drug: Ensartinib Hydrochloride

Test Standard Group

ACTIVE COMPARATOR

In Period 1, 32 healthy volunteers will divided evenly and randomly assigned to receive 1 dose of 100 mg capsules from either the test product or reference product. In Period 2 the same patients in each cohort will cross over and receive 1 dose of the 100 mg from the other group. These healthy volunteers will receive 1 dose from each of the 100 mg capsules manufactured by both processes.

Drug: Ensartinib Hydrochloride

Interventions

Ensartinib Hydrochloride DRUG

oral ALK inhibitor

Also known as: X-396

Reference Standard Group; Test Standard Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females of non-childbearing potential and males age 18\~55 years. Female subjects must be of non-childbearing potential (according to Appendix A), and have a negative serum pregnancy test at screening and a negative urine pregnancy test at (each) admission to the clinical research center.
• Male subjects with female partners of child-bearing potential must use two forms of acceptable contraception (according to Appendix A).
• Male body weight ≥ 50.0 kg or female body weight ≥ 45.0 kg; BMI between 18.0-32.0 kg/m2.
• Generally in good health, with no history of any (in the opinion of the Investigator) clinically significant, chronic or serious cardiovascular, hepatic, renal, respiratory, blood and lymphatic system, endocrine, immune, mental, neurological, gastrointestinal diseases. Additionally, no abnormalities of clinical significance in vital sign examination, physical examination, clinical laboratory tests (blood routine, urinalysis, blood biochemistry, drug test, nicotine test, etc.), and 12-lead ECG.
• No plan for sperm or egg donation during screening and for the next 6 months.
• Able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the Investigator, to comply with all the requirements of the study.
• Able to swallow oral medication.
• Able to communicate well with the investigator and understand and comply with all study requirements.

You may not qualify if:

• History of allergies or hypersensitivity to any excipient (microcrystalline cellulose, stearic acid, hydroxypropyl methylcellulose, or tartrazine, (a dye used in the ensartinib 100 mg capsules) or aspirin, or history of allergies to two or more kinds of drugs or foods.
• History of clinically significant, in the opinion of the investigator, dysphagia or history of any gastrointestinal diseases that may affect drug absorption.
• Received surgery within 3 months of the first dose, a history or have plans for a surgery during the study, that might affect absorption, distribution, metabolism, and excretion of drugs (e.g., gastrectomy, cholecystectomy, or other gastrointestinal tract surgery, except appendectomy).
• The presence of diseases with abnormal clinical manifestations that need to be excluded, in the opinion of the investigator, including but not limited to nervous, cardiovascular, blood and lymphatic system, immune, renal, hepatic, gastrointestinal, respiratory, metabolic and skeletal diseases.
• Venipuncture intolerance or history of blood phobia and needle sickness.
• Drug abuse within 3 months of the first dose.
• Donated ≥200 mL of blood (blood components) or had massive blood loss, received blood transfusion or blood products within 3 months of the first dose.
• Males who are planning a pregnancy with a partner or sperm donation in upcoming 6 months.
• The use of potent CYP3A inhibitors or inducers (see Appendix C in the trial protocol for details) and potent P-gp inhibitors (verapamil, cyclosporine A, dexverapamil) within 2 weeks before first dose.
• Received any prescription drug, over-the-counter drug, herbal drug or vitamins within 2 weeks of the first dose. An exception is made for incidental use of acetaminophen or an NSAID, which is allowed up to admission to the clinical research center.
• Received any vaccine within 4 weeks of the first dose.
• Excessive smoking (more than 5 cigarettes/day) within 3 months of the first dose, or disagreed on avoiding use of any tobacco products during the trial.
• Excessive alcohol use (more than 14 units of alcohol per week) (1 unit of alcohol ≈ 360 mL of beer, 45 mL of liquor at 40% ABV, or 150 mL of wine) within 3 months of the first dose, or unwilling to quit alcohol during the trial.
• Excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 250 ml for each cup) every day within 3 months of the first dose (amount based on investigator opinion)
• Consumption of excessive dragon fruit, mango, pomelo, lime, carambola, or food or beverage products prepared within 7 days of the first dose (amount based on investigator opinion).

Sponsors & Collaborators

• Xcovery Holdings, Inc.: lead

Study Sites (1)

ICON - Early Development Services

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

ensartinib

Study Officials

• Giovanni Selvaggi, MD

  Xcovery Holdings, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: December 27, 2022
• Study Start: November 29, 2022
• Primary Completion: January 18, 2023
• Study Completion: August 8, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)