BioequivalencyPhase 1NCT05665283
A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions
A Phase 1 study testing Ensartinib Hydrochloride in people with Bioequivalency, run by Xcovery Holdings, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalency
- What is being tested?
- Ensartinib Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2022to 8 Aug 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- Have a special diet requirement and cannot accept an uniform diet.
- The presence of abnormal vital sign findings of clinical significance. Normal ranges for reference (including cutoffs): systolic blood pressure 90~139 mmHg, diastolic blood pressure 50-89 mmHg, pulse 40-100 beats/min, temperature (oral) 35.4-37.7 °C, and breathing 10-20 breaths/min at a sitting position. The specific results are comprehensively judged by the investigator.
- Abnormal findings in any item of laboratory tests and auxiliary tests, which are of clinical significance at the investigator's discretion.
- Subject has any history of human immunodeficiency virus (HIV) or immunodeficiency or known diagnosis of hepatitis B or C.
- Subject has history or diagnosis of cancer with the exception of basal cell carcinoma treated more than 3 years prior to first dose and without a recurrence.
- An alcohol level greater than 0.0 mg/100mL as indicated by an alcohol breath test (ABT) or drug abuse screening test (morphine, methamphetamine, ketamine, ecstasy, and cannabis) positive.
- Between screening and (first) admission on day -1: Those who had diseases or took drugs ineligible for enrollment in the opinion of the investigator in this period; Those who ate methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) or grapefruit (juice) from 48 hours (2 days) prior to (first) admission.
- Previous participation in this study or subjects that are deemed by the investigator as not appropriate for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON - Early Development Services
Lenexa, Kansas, 66219
About this study
Official title: A Randomized Open Label Crossover Single Dose Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers Under Fasted Conditions
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.
Read the detailed description
A Phase I, randomized, open-label single dose, 2-part, crossover bioequivalence study under fasted conditions to compare 100 mg capsules manufactured using the proposed commercial manufacturing process to the corresponding capsules which were utilized in the Phase III clinical study manufactured by a different process. A total of 32 healthy subjects were divided evenly and were randomized into 1 of the 2 treatment sequences (T-R or R-T) prior to Period 1 dosing. Subjects received the test product (100 mg ensartinib hydrochloride capsules manufactured with the registration stability process) or the reference product (100 mg ensartinib hydrochloride capsules utilized in the Phase 3 trial) according to their assigned treatment sequence.
The single dose crossover study will have a minimum washout period of 14 days.
- Conditions
- Bioequivalency
- Being tested
- Ensartinib Hydrochloride
- Keywords
- Bioequivalency, Phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensartinib HydrochlorideDrug
Also called X-396
oral ALK inhibitor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ensartinib Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed concentration
Measured: 14 Days
AUC(0-t)
Area under the concentration time curve from time 0 to time of the last quantifiable
Measured: 14 Days
AUC(0-∞)
Area under the concentration time curve from time 0 to infinity
Measured: 14 Days
Secondary outcomes (3)
tmax
Time to reach maximum observed plasma concentration
Measured: 14 Days
t1/2
Apparent terminal elimination half life
Measured: 14 Days
lz
Terminal Phase elimination rate constant
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start29 Nov 2022
- Primary completion18 Jan 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalencyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xcovery Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni Selvaggi, MD, Principal investigator, Xcovery Holdings, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665283
- Sponsor's protocol ID
- XCV-X396-ONC-103
- Status last verified
- Feb 2024
- First submitted
- 21 Oct 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Crossover Single Dose Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT05665283
- Acronym / sponsor ID
- XCV-X396-ONC-103
- Conditions
- Bioequivalency
- Keywords
- Bioequivalency, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Xcovery Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 27 Dec 2022 (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 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.
Detailed description
A Phase I, randomized, open-label single dose, 2-part, crossover bioequivalence study under fasted conditions to compare 100 mg capsules manufactured using the proposed commercial manufacturing process to the corresponding capsules which were utilized in the Phase III clinical study manufactured by a different process. A total of 32 healthy subjects were divided evenly and were randomized into 1 of the 2 treatment sequences (T-R or R-T) prior to Period 1 dosing. Subjects received the test product (100 mg ensartinib hydrochloride capsules manufactured with the registration stability process) or the reference product (100 mg ensartinib hydrochloride capsules utilized in the Phase 3 trial) according to their assigned treatment sequence.
The single dose crossover study will have a minimum washout period of 14 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Standard Group | Active comparator | Drug: Ensartinib HydrochlorideIn 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. |
| Test Standard Group | Active comparator | Drug: Ensartinib HydrochlorideIn 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
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 |
|---|---|---|
| Ensartinib HydrochlorideAlso: X-396oral ALK inhibitor | Drug | Reference Standard Group, Test Standard Group |
Primary outcome
Cmax
Time frame: 14 Days
Maximum observed concentration
AUC(0-t)
Time frame: 14 Days
Area under the concentration time curve from time 0 to time of the last quantifiable
AUC(0-∞)
Time frame: 14 Days
Area under the concentration time curve from time 0 to infinity
3 secondary outcomes
tmax
Time frame: 14 Days
t1/2
Time frame: 14 Days
lz
Time frame: 14 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 20 Feb 2024.
- Individual participant dataSharing planned: No
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.
Giovanni Selvaggi, MD principal investigator
Xcovery Holdings, Inc.
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 Ensartinib Hydrochloride in people with Bioequivalency, run by Xcovery Holdings, Inc. at 1 site in United States.
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 8 inclusion and 23 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 20 Feb 2024. 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 United States. 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?
Cmax (time frame: 14 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 20 Feb 2024.