Healthy Male VolunteersPhase 1NCT03941340
Study Evaluating the Mass Balance And Biotransformation of Single Dose[14C] AST2818 in Chinese Healthy Male Volunteers
A Phase 1 study testing [14]-AST2818 in people with Healthy Male Volunteers, run by Allist Pharmaceuticals, Inc. at 1 site in China.
Trial summary
Study to Evaluate the Mass Balance and Biotransformation of Single Dose[14C] AST2818 in Chinese Healthy Male Volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- [14]-AST2818
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2019to 6 Sep 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult;
- Body weight: The body mass index varies in the range of 19 - 26 kg/m2 (including 19 and 26 kg/m2);
- Signing the informed consent forms by oneself ;
- Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.
Who cannot join
- Those with abnormal examination and clinical significance ( including Physical examination, routine laboratory examination (blood routine, urine routine, fecal routine + Occult blood, blood biochemistry, blood coagulation routine, thyroid function), 12-lead electrocardiogram, X-ray (positive position), abdominal B-mode ultrasonography (liver, gallbladder, pancreas, spleen and kidney), etc)；
- Those with routine urine examination showed positive urinary protein；
- Those with QTcF > 470 msec in resting state, corrected by ECG during screening period；
- Those with HBsAg , HBeAg and HCVAb were positive；
- Those with HIVAb was positive；
- Those with treponema pallidum Ab was positive；
Show all 27Show fewer
- Those who take any drugs that inhibit or induce the CYP450 enzyme (i.e., inducers- barbiturates, tegretol, phenytoin, rifampicin, hexadecadrol, rifabutin, rifapentini; inhibitors- SSRI-antidepressant, cimetidine, diltiazem, macrolides, verapamil, imidazoles- antifungal drugs) 30 days prior to screening period；
- Those who take any drug, health care products (including vitamins), chinese traditional medicine 14 days prior to screening period；
- Those who participated other clinical trials or took the investigational drug 3 months prior to screening period, or prepare to take part in other clinical trials within 1 month after finishing this trial；
- Those who have history of organic heart disease, heart failure, myocardial infarction, angina, unexplained arrhythmia, torsional ventricular tachycardia, ventricular tachycardia and QT prolonged syndrome, or have the family history (Genetic proof or a close relative of sudden cardiac death at a young age) and symptom of QT prolonged syndrome ；
- Those who have severe disease of ophthalmic system, e.g., corneal, conjunctiva and eyelid diseases;
- Those who have undergone major surgery within the first 6 months of the screening period or have no complete surgical incision; major procedures include, but are not limited to, any operator with significant bleeding risk, prolonged general anesthesia, or incisional biopsy or significant traumatic injury;
- Those who have but not limited to circulatory system, endocrine system, nervous system, digestive system, urinary system, or have the history of blood, immunity spirit and metabolism diseases；
- Those who have allergic constitution, including being definitely allergic to TKIs or any ingredients of this trial drugs，any food materials or have special demands for foods，and cannot comply with the rule of unified diet；
- Those who have history of hand and foot syndrome；
- Those who have haemorrhoids or perianal disease with regular/ongoing hematochezia；
- Those who have coagulation dysfunction or other diseases of the blood system;
- Those who have history of tumor；
- Those who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease；
- Those who have history of alcohol abuse (it was defined as that the daily alcohol consumption was higher than the following criteria: the weekly alcohol consumption was higher than 14 units of alcohol (1 unit= 360 ml beers/45 ml liquor containing 40% alcohol/150ml grape wine) 6 months prior to screening period, or the alcohol breath test results ≥20 mg/dl during screening period；
- Those who smoked daily >5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study；
- Those have history of drug abuse or taking soft drug (i.e., marihuana) 3 months prior to screening period or taking hard drugs (i.e., cocaine, amphetamines, benzodiazepine, etc.); or the results of urine test in drugs were positive;
- Those who were used to drink grapefruit juice or overconsumption of tea, coffee, and the drink with caffeine; and cannot give up them during test；
- Those who need long-term exposure to radiation, or who have been exposed to significant radiation (> 2 chest/abdominal CT scans or more than 3 other X-ray scans) or who have participated in the labeling test of radiopharmaceuticals within one year before the test;
- Those who have fertility planning within the range of starting trial - 1 year after finishing trial, or disagree with the regulation and their mate should take strict contraception (taking condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives and subcutaneous implants, etc.)；
- Those who have excessive bleeding or blood donation (400ml) 3 months prior to screening period, or planned to donate blood 1 month after finishing this trial；
- Those who cannot complete this study because of other reasons, or any factors judged by investigator that the participants cannot meet.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: A Phase I Mass Balance and Biotransformation Study of Orally Administered [14C]-Alflutinib Mesylate (AST2818) in Chinese Healthy Male Volunteers
Study to Evaluate the Mass Balance and Biotransformation of Single Dose[14C] AST2818 in Chinese Healthy Male Volunteers
Read the detailed description
A Phase I Mass Balance and Biotransformation Study of Orally Administered [14C]-Alflutinib Mesylate (AST2818) in Chinese Healthy Male Volunteers
- Conditions
- Healthy Male Volunteers
- Being tested
- [14]-AST2818
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14]-AST2818Drug
Volunteer will receive a single oral dose of 80 mg /100 u Ci [14C]-AST2818 as a solution on Day 1
| Study group | Role | What they receive |
|---|---|---|
| [14C]-AST2818 80mg (oral solution) | Experimental | Volunteers will receive 80 mg [14C]-AST2818 containing a nominal 100 μCi activity, administered by mouth, as a solution. Receives: Drug: [14]-AST2818 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distribution of AST2818 in the whole blood and plasma and whole radioactive pharmacokinetics following the single orally administered [14C]-AST2818 in healthy male volunteers.
The percentage of radioactive dose of [14C] radiolabelled AST2818 recovered in blood and in total, up to Day 85（p.s:The administration time on the first day is 7:30 am）
Measured: Blood samples (hrs) - 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, every 24 to 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848 and 2016.
Quantitive analysis of whole radioactivity of excrement of orally administered [14C]-AST2818 in healthy volunteers to obtain the mass balance data and the main excretion pathway in human body.
The percentage of radioactive dose of [14C] radiolabelled AST2818 recovered in urine, faeces and in total, up to Day 85（p.s:The administration time on the first day is 7:30 am）
Measured: Urine and faeces (hrs): 0-4, 4-8, 8-12, 12-24, every 24 to 504, 624-672, 792-840, 960-1008, 1128-1176, 1296-1344, 1464-1512, 1632-1680, 1800-1848 and 1968-2016.
Quantitive analysis of the concentrations of AST2818 and AST5902 (Metabolite of AST2818) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data;
The concentrations of AST2818 and AST5902 in plasma up to Day 85（p.s:The administration time on the first day is 7:30 am）
Measured: Blood samples (hrs) - 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, every 24 to 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848 and 2016.
Proportion of different metabolites in healthy volunteers after oral administration of [14C]-AST2818
Proportion of different metabolites
Measured: Blood samples (hrs) - 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, every 24 to 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848 and 2016.
Types of adverse events assessed by CTCAE v5.0 that occurred during the trial
Types of adverse events
Measured: Baseline (Day-1) to Day 85（p.s:The administration time on the first day is 7:30 am）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start8 Apr 2019
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies of the same condition, open and under way.
- More trials run by Allist Pharmaceuticals, Inc.The 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LiYan Miu, Principal investigator, First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941340
- Sponsor's protocol ID
- 20190130
- Status last verified
- Jan 2020
- First submitted
- 24 Apr 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Mass Balance and Biotransformation Study of Orally Administered [14C]-Alflutinib Mesylate (AST2818) in Chinese Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03941340
- Acronym / sponsor ID
- 20190130
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 7 May 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.
Study to Evaluate the Mass Balance and Biotransformation of Single Dose[14C] AST2818 in Chinese Healthy Male Volunteers
Detailed description
A Phase I Mass Balance and Biotransformation Study of Orally Administered [14C]-Alflutinib Mesylate (AST2818) in Chinese Healthy Male Volunteers
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-AST2818 80mg (oral solution) | Experimental | Drug: [14]-AST2818Volunteers will receive 80 mg [14C]-AST2818 containing a nominal 100 μCi activity, administered by mouth, as a solution. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult;
- Body weight: The body mass index varies in the range of 19 - 26 kg/m2 (including 19 and 26 kg/m2);
- Signing the informed consent forms by oneself ;
- Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.
Key exclusion criteria (27 listed)
- Those with abnormal examination and clinical significance ( including Physical examination, routine laboratory examination (blood routine, urine routine, fecal routine + Occult blood, blood biochemistry, blood coagulation routine, thyroid function), 12-lead electrocardiogram, X-ray (positive position), abdominal B-mode ultrasonography (liver, gallbladder, pancreas, spleen and kidney), etc)；
- Those with routine urine examination showed positive urinary protein；
- Those with QTcF > 470 msec in resting state, corrected by ECG during screening period；
- Those with HBsAg , HBeAg and HCVAb were positive；
- Those with HIVAb was positive；
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 |
|---|---|---|
| [14]-AST2818Volunteer will receive a single oral dose of 80 mg /100 u Ci [14C]-AST2818 as a solution on Day 1 | Drug | [14C]-AST2818 80mg (oral solution) |
Primary outcome
The distribution of AST2818 in the whole blood and plasma and whole radioactive pharmacokinetics following the single orally administered [14C]-AST2818 in healthy male volunteers.
Time frame: Blood samples (hrs) - 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, every 24 to 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848 and 2016.
The percentage of radioactive dose of [14C] radiolabelled AST2818 recovered in blood and in total, up to Day 85（p.s:The administration time on the first day is 7:30 am）
Quantitive analysis of whole radioactivity of excrement of orally administered [14C]-AST2818 in healthy volunteers to obtain the mass balance data and the main excretion pathway in human body.
Time frame: Urine and faeces (hrs): 0-4, 4-8, 8-12, 12-24, every 24 to 504, 624-672, 792-840, 960-1008, 1128-1176, 1296-1344, 1464-1512, 1632-1680, 1800-1848 and 1968-2016.
The percentage of radioactive dose of [14C] radiolabelled AST2818 recovered in urine, faeces and in total, up to Day 85（p.s:The administration time on the first day is 7:30 am）
Quantitive analysis of the concentrations of AST2818 and AST5902 (Metabolite of AST2818) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data;
Time frame: Blood samples (hrs) - 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, every 24 to 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848 and 2016.
The concentrations of AST2818 and AST5902 in plasma up to Day 85（p.s:The administration time on the first day is 7:30 am）
Proportion of different metabolites in healthy volunteers after oral administration of [14C]-AST2818
Time frame: Blood samples (hrs) - 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, every 24 to 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848 and 2016.
Proportion of different metabolites
Types of adverse events assessed by CTCAE v5.0 that occurred during the trial
Time frame: Baseline (Day-1) to Day 85（p.s:The administration time on the first day is 7:30 am）
Types of adverse events
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 6 Jan 2020.
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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.
LiYan Miu principal investigator
First Affiliated Hospital of Soochow 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 [14]-AST2818 in people with Healthy Male Volunteers, run by Allist Pharmaceuticals, Inc. 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 4 inclusion and 27 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 6 Jan 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?
The distribution of AST2818 in the whole blood and plasma and whole radioactive pharmacokinetics following the single orally administered [14C]-AST2818 in healthy male volunteers. (time frame: Blood samples (hrs) - 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, every 24 to 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848 and 2016.). The study lists 5 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 6 Jan 2020.