NSCLCPhase 1NCT04032821
To Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Alkotinib Capsules in Healthy Subjects
A Phase 1 study testing Alkotinib（300mg) in people with NSCLC, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
To evaluate the safety and tolerability of food to Alkotinib Capsules in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- NSCLC
- What is being tested?
- Alkotinib（300mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2019to 16 Dec 2019
- 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
- sign the informed consent before the clinicaltrial, and fully understand the clinicaltrial content, process and possible adverse event.
- Be able to complete the research according to the clinicaltrial protocol.
- Subjects (including sexual partners) were willing to be screened up to 6 months after the last study drug administration No family planning and voluntary effective contraceptive measures, the specific contraceptive measures see appendix.
- Male and female subjects aged 18 to 55 years (including 18 and 55 years).
- The weight of male subjects should not be less than 50 kg and that of female subjects should not be less than 45 kg. The body of the Body mass index (BMI) = weight (kg)/height 2 (m2), with a BMI of 18~28 kg/m2 range (including critical value).
- Normal or abnormal physical examination and vital signs have n
- clinical significance.
Who cannot join
- Smoking more than 5 cigarettes per day during the first 3 months of the study
- Allergic constitution (multiple drug and food allergies).
- A history of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = beer 285)ML, or liquor 25 mL, or wine 100 mL)
- Blood donation or massive blood loss within 3 months prior to clinical trial screening (> 450ml)
- Any drugs that alter liver enzyme activity were taken 28 days before screening.
- Within 14 days prior to screening，took any prescription, over-the-counter, vitamin products or Herbs.
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- Special diet (including dragon fruit, mango, grapefruit, etc.) or drama in 2 weeks，before screening strenuous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
- CYP3A inhibitors (e.g., atanavir, talymycin, clarithromycin, etc.), CYP3A inducers (e.g Drugs metabolized by CYP2C8 (such as amodiaquine, silvastatin, etc.) and CYP2C9 metabolism Drugs such as diclofenac, ibuprofen, etc.
- There have been major changes in diet or exercise habits recently.
- Have taken a study drug or participated in a clinical trial of the drug within three months prior to taking the study drug Check.
- A history of dysphagia or any gastrointestinal illness that affects drug absorption, cholecystitis or cholecystectomy In addition to the history;
- Any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenum Ulcer etc.
- Subjects who could not tolerate standard meals
- Abnormal ecg has clinical significance, or QTc interval >450 ms, or heart rate or pulse < 55 times /Points.
- Any pulmonary disease, including but not limited to interstitial pneumonia, allergic pneumonia, occlusion.Bronchiolitis, pulmonary interstitial fibrosis,interstitial lung disease (ILD), or any pre-existing disease History.
- Female subjects were lactating during the screening period or during the test or had positive serum pregnancy results sex.
- Clinical laboratory examination has clinical significance abnormality, or other clinical findings within 12 months before screening the following diseases (including but not limited to gastrointestinal tract, heart, lung, kidney,Liver, pancreas, nerve, blood, endocrine, tumor, immune, mental or cardiovascular diseases）.
- Screening for viral hepatitis (including hepatitis b and c), AIDS antibody and syphilis spirochete antibody positive.
- Ingested chocolate, any caffeine containing it or the yellow purinate-rich drug 48 hours before taking it.
- Any use of alcohol within 48 hours prior to taking the study drug.
- Positive urine screening or drug use in the past 5 years.
- Subjects considered to have other factors unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The first Bethune hospital of jilin university
Changchun, Jilin, 130021
About this study
Official title: To Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Alkotinib Capsules in Healthy Subjects,A Single Center, Open, Randomized, Single Dose, Two Period, Two Sequence, Crossover Phase I Clinical Trial
To evaluate the safety and tolerability of food to Alkotinib Capsules in healthy subjects
Read the detailed description
Alkotinib is an insulin receptor tyrosine kinase inhibitor that selectively inhibits anaplastic lymphoma Kinase and proto-oncogene protein ROS1。Alkotinib is expected to be used in the treatment of ALK positive and ROS1 positive metastatic non-small cell lung Cancer and other cancers include patients with non-small cell lung cancer who are resistant to treatment with the first generation ALK inhibitor, such as kezotinib。
- Conditions
- NSCLC
- Being tested
- Alkotinib（300mg)
- Keywords
- Pharmacokinetics, Alkotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkotinib（300mg)Drug
- First empty stomach, after the meal.2. After eating first, after fasting.
| Study group | Role | What they receive |
|---|---|---|
| Alkotinib（300mg）First empty stomach, after the meal | Experimental | Alkotinib（300mg），Subjects need to be fasting overnight for at least 10 hours before being warmed to 240 mL on an empty stomach Water service, lunch 4 hours later, dinner 10 hours later. Receives: Drug: Alkotinib（300mg) |
| Alkotinib（300mg）After eating first, after fasting | Experimental | Alkotinib（300mg），Subjects need to be fasting for at least 10 hours overnight, starting 30 min before taking the medication A standard meal (800-1000 CAL) can be taken before taking the medicine, and 240 mL warm water can be taken after the meal Lunch hours later, dinner 10 hours later. Receives: Drug: Alkotinib（300mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum blood concentration
Measured: up to 120 hours
AUC0-t
Area under the plasma concentration - time curve from 0 to the last measurable concentration time point t
Measured: up to 120 hours
AUC0-∞
Area under the concentration - time curve from zero to infinity
Measured: up to 6 months
Secondary outcomes (5)
Tmax
To the maximum blood concentration time
Measured: up to 6 months
t1/2
Plasma drug half-life
Measured: up to 6 months
λz
14/5000 The rate constant of plasma concentration elimination in terminal phase
Measured: up to 6 months
CL/F
Apparent clearance
Measured: up to 6 months
VZ/F
Apparent volume
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start20 Nov 2019
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- Each subject was randomly given Alkotinib capsules on an empty stomach or after a meal, and the cleaning period between the two dosages was set as 14 days. The actual dosing time was subject to the original clinical records. After admission to the ward on day -1 (1 day before drug administration), subjects will eat light dinner A 1:1 ratio was randomly assigned to 2 sequences (1=AB, 2=BA). Each subject was subject to two cycles of trials, and the study drug was taken once on an empty stomach or after meal according to the dosing sequence in the randomization table.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yanhua Ding, MD, Study chair, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032821
- Sponsor's protocol ID
- ZGALK003
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2019
- Last updated
- 12 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share date of the trial
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Alkotinib Capsules in Healthy Subjects,A Single Center, Open, Randomized, Single Dose, Two Period, Two Sequence, Crossover Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT04032821
- Acronym / sponsor ID
- ZGALK003
- Conditions
- NSCLC
- Keywords
- Pharmacokinetics, Alkotinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 25 Jul 2019 (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.
To evaluate the safety and tolerability of food to Alkotinib Capsules in healthy subjects
Detailed description
Alkotinib is an insulin receptor tyrosine kinase inhibitor that selectively inhibits anaplastic lymphoma Kinase and proto-oncogene protein ROS1。Alkotinib is expected to be used in the treatment of ALK positive and ROS1 positive metastatic non-small cell lung Cancer and other cancers include patients with non-small cell lung cancer who are resistant to treatment with the first generation ALK inhibitor, such as kezotinib。
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each subject was randomly given Alkotinib capsules on an empty stomach or after a meal, and the cleaning period between the two dosages was set as 14 days. The actual dosing time was subject to the original clinical records. After admission to the ward on day -1 (1 day before drug administration), subjects will eat light dinner A 1:1 ratio was randomly assigned to 2 sequences (1=AB, 2=BA). Each subject was subject to two cycles of trials, and the study drug was taken once on an empty stomach or after meal according to the dosing sequence in the randomization table.
| Arm | Type | Receives |
|---|---|---|
| Alkotinib（300mg）First empty stomach, after the meal | Experimental | Drug: Alkotinib（300mg)Alkotinib（300mg），Subjects need to be fasting overnight for at least 10 hours before being warmed to 240 mL on an empty stomach Water service, lunch 4 hours later, dinner 10 hours later. |
| Alkotinib（300mg）After eating first, after fasting | Experimental | Drug: Alkotinib（300mg)Alkotinib（300mg），Subjects need to be fasting for at least 10 hours overnight, starting 30 min before taking the medication A standard meal (800-1000 CAL) can be taken before taking the medicine, and 240 mL warm water can be taken after the meal Lunch hours later, dinner 10 hours later. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- sign the informed consent before the clinicaltrial, and fully understand the clinicaltrial content, process and possible adverse event.
- Be able to complete the research according to the clinicaltrial protocol.
- Subjects (including sexual partners) were willing to be screened up to 6 months after the last study drug administration No family planning and voluntary effective contraceptive measures, the specific contraceptive measures see appendix.
- Male and female subjects aged 18 to 55 years (including 18 and 55 years).
- The weight of male subjects should not be less than 50 kg and that of female subjects should not be less than 45 kg. The body of the Body mass index (BMI) = weight (kg)/height 2 (m2), with a BMI of 18~28 kg/m2 range (including critical value).
Key exclusion criteria (22 listed)
- Smoking more than 5 cigarettes per day during the first 3 months of the study
- Allergic constitution (multiple drug and food allergies).
- A history of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = beer 285)ML, or liquor 25 mL, or wine 100 mL)
- Blood donation or massive blood loss within 3 months prior to clinical trial screening (> 450ml)
- Any drugs that alter liver enzyme activity were taken 28 days before screening.
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 |
|---|---|---|
| Alkotinib（300mg)1. First empty stomach, after the meal.2. After eating first, after fasting. | Drug | Alkotinib（300mg）After eating first, after fasting, Alkotinib（300mg）First empty stomach, after the meal |
Primary outcome
Cmax
Time frame: up to 120 hours
Maximum blood concentration
AUC0-t
Time frame: up to 120 hours
Area under the plasma concentration - time curve from 0 to the last measurable concentration time point t
AUC0-∞
Time frame: up to 6 months
Area under the concentration - time curve from zero to infinity
5 secondary outcomes
Tmax
Time frame: up to 6 months
t1/2
Time frame: up to 6 months
λz
Time frame: up to 6 months
CL/F
Time frame: up to 6 months
VZ/F
Time frame: up to 6 months
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 12 Apr 2021.
- Individual participant dataSharing planned: No. No plan to share date of the trial
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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.
yanhua Ding, MD study chair
The First Hospital of Jilin University
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 Alkotinib（300mg) in people with NSCLC, run by Suzhou Zelgen Biopharmaceuticals 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 22 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 12 Apr 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?
Cmax (time frame: up to 120 hours). 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 12 Apr 2021.