Locally Advanced or Metastatic NSCLCPhase 1NCT04360915
Assessing the Pharmacokinetics Effects of Food on ASK120067 in Single Oral Administration in Chinese Healthy Subjects
A Phase 1 study testing ASK120067 and ASK120067 in fed condition in people with Locally Advanced or Metastatic NSCLC, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the pharmacokinetic characteristics of ASK120067 and CCB4580030 after the single oral administration of ASK120067 in fast and after a high-fat meal in healthy Chinese subjects, and to evaluate the effect of food on the bioavailability of ASK120067.To evaluate the safety of ASK120067 tablets administered… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced or Metastatic NSCLC
- What is being tested?
- ASK120067 and ASK120067 in fed condition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2019to 30 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Healthy subjects aged 18 or above and 45 or below, male and female;
- 2) The weight of male subjects shall not be less than 50 kg, and that of female subjects shall not be less than 45 kg.Body mass index (BMI) = weight (kg)/height2 (m2), BMI = Within the range of 19.0~26.0 (including the critical value);
- 3) Normal or abnormal physical examination (physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, frontal and lateral chest radiographs, etc.) during the screening period has no clinical significance;
- 4) Subjects (including male subjects) are willing to have no pregnancy plan from the screening date to 6 months after the last dose, and are willing to take effective contraceptive measures;
- 5) Subjects should sign the informed consent before the test, fully understand the test content, process and possible adverse reactions, have good communication with researchers and complete the test according to the test plan.
Who cannot join
- 1) patients with clinical significance who are abnormal by comprehensive physical examination, vital signs examination, routine laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram, and positive and lateral chest radiographs;
- 2) HBSAg HCVAb HIVAb, treponema palliatum antibody and other test results were positive;
- 3) QTc interphase abnormality (QTc>450ms) with clinical significance;
- 4) participated in the drug clinical trial within 3 months before the trial;
- 5) taking any medication 14 days before the trial;
- 6) surgical resection history, such as: hepatectomy, nephrectomy, digestive organ (gallbladder) resection;
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- 7) history of tuberculosis;
- 8) past history of deep vein thrombosis/other thromboembolic events, abnormal coagulation factors, thrombocytopenia, or abnormal platelet function;
- 9) previous history of interstitial lung disease (ILD), drug-induced ILD, radioactive pneumonia requiring steroid treatment, or clinically active ILD with evidence;
- 10) allergic or hypersensitive to ASK120067 experimental active ingredients or inactive excipients, drugs with similar chemical structure to the experimental drugs or drugs with the same target, allergic to two or more drugs and food;
- 11) there are swallowing difficulties or gastrointestinal diseases affecting drug absorption;
- 12) have any disease that increases the risk of bleeding, such as acute gastritis or gastric and duodenal ulcers;
- 13) habitual constipation or diarrhea;
- 14) heavy drinking and/or a history of excessive drinking (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
- 15) alcohol breath test > 0.0mg /100mL;
- 16) drug abuse screening positive;
- 17) smoking history, smoking more than 5 cigarettes per day in the first 3 months of the screening period or habitual use of nicotine-containing products, and unable to quit during the trial;
- 18) those with positive urine nicotine detection results at the screening stage;
- 19) having a history of blood or needle sickness;
- 20) habitual consumption and consumption of special diet (including grapefruit juice, star fruit, pitaya fruit, etc.) within 7 days before the test, or the presence of other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
- 21) blood donation or massive blood loss (> 400 mL) within 3 months prior to the trial;
- 22) an acute illness or accident occurs during the screening period;
- 23) the female subjects were lactating, or the pregnancy test results were positive, or they had unprotected sex within 2 weeks before the screening date;
- 24) there are other conditions that the researcher thinks are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
To evaluate the pharmacokinetic characteristics of ASK120067 and CCB4580030 after the single oral administration of ASK120067 in fast and after a high-fat meal in healthy Chinese subjects, and to evaluate the effect of food on the bioavailability of ASK120067.To evaluate the safety of ASK120067 tablets administered orally in fast and fed.
- Conditions
- Locally Advanced or Metastatic NSCLC
- Being tested
- ASK120067, ASK120067 in fed condition
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASK120067Drug
Take ASK120067 tablets orally in first day at 160 mg in fast condition.
ASK120067 in fed conditionDietary supplement
Take ASK120067 tablets orally in first day at 160 mg in fed condition.
| Study group | Role | What they receive |
|---|---|---|
| ASK120067 in fast condition | Experimental | Take ASK120067 tablets orally once in the first day at 160mg in fast condition. Receives: Drug: ASK120067 |
| ASK120067 in fed condition | Experimental | Take ASK120067 tablets orally once in the first day at 160mg in fed condition. Receives: Dietary Supplement: ASK120067 in fed condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out maximum concentration
Measured: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
AUC
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out area under the plasma concentration-time curve
Measured: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
Secondary outcomes (6)
Tmax
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out time to reach maximum concentration
Measured: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
t1/2
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent end elimination half-life
Measured: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
CL/F
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent clearance
Measured: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
Vd/F
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent volume of distribution
Measured: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
λz
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent terminal elimination rate constant
Measured: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
Incidence and Severity of Treatment-Emergent Adverse Events
Assessed by number and severity of adverse events as recorded on the case report form.
Measured: Adverse events will be collected from baseline until 12 days after the administration and the follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start9 Dec 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic NSCLCStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zourong Ruan, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360915
- Sponsor's protocol ID
- ASK-LC-120067-Ib
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Pharmacokinetics Effects of Food on ASK120067 in Single Oral Administration in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT04360915
- Acronym / sponsor ID
- ASK-LC-120067-Ib
- Conditions
- Locally Advanced or Metastatic NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 24 Apr 2020 (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 pharmacokinetic characteristics of ASK120067 and CCB4580030 after the single oral administration of ASK120067 in fast and after a high-fat meal in healthy Chinese subjects, and to evaluate the effect of food on the bioavailability of ASK120067.To evaluate the safety of ASK120067 tablets administered orally in fast and fed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASK120067 in fast condition | Experimental | Drug: ASK120067Take ASK120067 tablets orally once in the first day at 160mg in fast condition. |
| ASK120067 in fed condition | Experimental | Dietary Supplement: ASK120067 in fed conditionTake ASK120067 tablets orally once in the first day at 160mg in fed condition. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1) Healthy subjects aged 18 or above and 45 or below, male and female;
- 2) The weight of male subjects shall not be less than 50 kg, and that of female subjects shall not be less than 45 kg.Body mass index (BMI) = weight (kg)/height2 (m2), BMI = Within the range of 19.0~26.0 (including the critical value);
- 3) Normal or abnormal physical examination (physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, frontal and lateral chest radiographs, etc.) during the screening period has no clinical significance;
- 4) Subjects (including male subjects) are willing to have no pregnancy plan from the screening date to 6 months after the last dose, and are willing to take effective contraceptive measures;
- 5) Subjects should sign the informed consent before the test, fully understand the test content, process and possible adverse reactions, have good communication with researchers and complete the test according to the test plan.
Key exclusion criteria (24 listed)
- 1) patients with clinical significance who are abnormal by comprehensive physical examination, vital signs examination, routine laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram, and positive and lateral chest radiographs;
- 2) HBSAg HCVAb HIVAb, treponema palliatum antibody and other test results were positive;
- 3) QTc interphase abnormality (QTc>450ms) with clinical significance;
- 4) participated in the drug clinical trial within 3 months before the trial;
- 5) taking any medication 14 days before the trial;
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 |
|---|---|---|
| ASK120067Take ASK120067 tablets orally in first day at 160 mg in fast condition. | Drug | ASK120067 in fast condition |
| ASK120067 in fed conditionTake ASK120067 tablets orally in first day at 160 mg in fed condition. | Dietary supplement | ASK120067 in fed condition |
Primary outcome
Cmax
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out maximum concentration
AUC
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out area under the plasma concentration-time curve
6 secondary outcomes
Tmax
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
t1/2
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
CL/F
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
Vd/F
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
λz
Time frame: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)
Incidence and Severity of Treatment-Emergent Adverse Events
Time frame: Adverse events will be collected from baseline until 12 days after the administration and the follow-up period
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 29 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Zourong Ruan principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 ASK120067 and ASK120067 in fed condition in people with Locally Advanced or Metastatic NSCLC, run by Jiangsu Aosaikang Pharmaceutical 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 5 inclusion and 24 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 29 Apr 2020. 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: Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)). The study lists 2 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 29 Apr 2020.