Healthy SubjectsPhase 1NCT06186583
A Mass Balance Study of [14C]ABSK021
A Phase 1 study testing Pimicotinib（ABSK021） in people with Healthy Subjects, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
Trial summary
This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK021 in healthy adult male subjects. The study plans to enroll 6 to 10 healthy male subjects to ensure at least 6 evaluable subjects. 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 Subjects
- What is being tested?
- Pimicotinib（ABSK021）
- 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
- 13 Dec 2023to 30 Jul 2024
- 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
- Subjects who fully understand the content, procedures and possible adverse reactions before the study, and voluntarily sign the informed consent form, and can complete the study in accordance with the requirements in the protocol;
- Healthy male subjects aged 18 to 45 years (including 18 and 45 years) at screening;
- Weight ≥ 50 kg, body mass index (BMI) between 19 and 28 (including 19 and 28), BMI = weight (kg)/height (m) 2;
- Subjects must have regular defecation in the past three months;
- Male subjects of childbearing potential must agree to use effective contraceptive methods during the study and within 12 months after administration of study drug . Male subjects must agree to not donate sperm during this period.
Who cannot join
- Abnormal and clinically significant complete physical examination, vital signs, digital rectal examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, stool routine + occult blood, thyroid function, etc.), 12-lead electrocardiogram, chest X-ray (anteroposterior position), abdominal B ultrasound (hepatobiliary, pancreas, spleen and kidney);
- Abnormal and clinically significant ophthalmic examination (slit lamp, intraocular pressure and fundus photography);
- Tested positive for any one of the following: serum hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, treponema pallidum antibody (Syphilis) screening;
- The baseline of heart rate corrected QT, QTcF interval prolongs > 450ms; family history of long QT syndrome (Note: QTc interval is corrected by Fridericia formula);
- Creatinine clearance (CrCL) ≤ 60 mL/min, calculated using the Cockcroft-Gault formula ;
- Subjects with a history of cardiovascular, respiratory, blood, liver, kidney, gastrointestinal, endocrine or nervous system diseases, for whom the absorption, metabolism or elimination of the drug are significantly affected, or for whom the investigator judges that the disease(s) may pose a risk when taking the test drug, interfere with the interpretation of the data, or affect the ability of the subjects to participate in the study;
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- Known or persistent mental disorders that may interfere with the subject's participation in the study, as judged by the investigator;
- Known history of allergy to any drug or food;
- Subjects who have participated in drug trials within 3 months before dosing.
- Subjects who have participated in this study or any other study related to ABSK021, and have previously exposed to ABSK021;
- Subjects who have used OATP1B1 inhibitors or strong CYP3A4 inhibitors or inducers (including grapefruit juice, grapefruit hybrids, pomegranates, carambola, grapefruit, Seville oranges and juice or other processed products) within 14 days prior to dosing;
- Subjects with factors that significantly affect drug absorption, distribution, metabolism and excretion, such as inability to take the test drug orally, obvious nausea and vomiting and malabsorption; Subjects with history of gastric or intestinal surgery or resection (appendectomy and hernia repair surgery is allowed);
- Subjects who are unwilling to comply with the dietary requirements/restrictions during the study. The specific dietary requirements are: (i) only eat the meals provided by the study sites during hospitalization, (ii) avoid consumption of OATP1B1 inhibitors or strong CYP3A4 inhibitors or inducers during this study;
- Subject whose weekly alcohol consumption is greater than 14 units (1 unit of alcohol is equivalent to approximately 360 mL beer, 45 mL of spirits with 40% alcohol or 150 mL wine) within 3 months before dosing, or whose alcohol breath test result is ≥ 20 mg/dl;
- Subjects who smoke more than 5 cigarettes per day (or an equivalent amount of tobacco or nicotine) within 3 months prior to dosing;
- Subjects with overdose of methylxanthine/caffeine in the past 6 months as judged by the investigator (overdose is defined as more than 6 units of caffeine per day. 1 unit of caffeine is equivalent to 177 mL of coffee, 355 mL of tea, 355 mL of cola or 85 grams of chocolate);
- Subjects with a history of bacterial, fungal, parasitic, viral (not including nasopharyngitis), mycobacterial infection within 45 days before dosing;
- Known history of drug abuse or tested positive in drug abuse screening;
- Subjects who have used or intend to use over-the-counter or prescription drugs, including herbal medicine, within 14 days prior to dosing and during the study;
- Subjects who have donated plasma within 30 days before dosing or blood within 3 months before screening, or have experienced blood loss of > 400 mL;
- A definite history of hemorrhoids; or perianal disease associated with regular hematochezia or ongoing bleeding, or habitual constipation/diarrhea;
- Subjects who have been vaccinated within 2 months prior to dosing, or intend to be vaccinated throughout the study;
- Subjects who have participated in the design or implementation of this project and their immediate family members (e.g., employees from Sponsor, CRO or research sites);
- Subjects who need to work in a condition with long-term radioactive exposure, or who have experienced significant radioactive exposure (≥ 2 chest/abdominal CTs, or ≥ 3 other types of X-rays) within 1 year prior to the study, or who have participated in studies with radiopharmaceutical labelling;
- Subjects with a history of needle sickness or blood sickness, who have difficulty or are intolerant to venipuncture;
- Subjects with any other factors that may influence the participation in the study, which may affect the subject's compliance with the protocol, interfere with the interpretation of the study results, or expose the subject to risk, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of SOOCHOW UNIVERSITY
Suzhou, Jiangsu, 215000
About this study
Official title: A Mass Balance Study of [14C]ABSK021 in Healthy Adult Male Chinese Subjects
This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK021 in healthy adult male subjects. The study plans to enroll 6 to 10 healthy male subjects to ensure at least 6 evaluable subjects.
Read the detailed description
Subjects will be screened within 14 days before dose administration (D-14 to D-3), and will be admitted to the trial ward two days before dose administration (D-2).
On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of [14C] ABSK021 in the fasted state.
All excreted urine and feces samples and blood samples at specified time points during 0-504 hours after dosing will be collected. Random feces within 48 hours prior to dosing and random urine within 24 hours prior to dosing will be collected as blank samples (if there are multiple blank samples, the most recent blank sample before dosing will be selected for analysis).
- Conditions
- Healthy Subjects
- Being tested
- Pimicotinib（ABSK021）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimicotinib（ABSK021）Drug
A standard meal should be given to the subjects in the evening before dosing. Then, the subjects should fast for at least 10 hours. Water is not prohibited overnight. The next morning, the subjects should administer study drug in fasted state with warm water. The total volume of warm water and suspension is approximately 240 mL. Water is prohibited from 1 hour before dosing to 1 hour after dosing. No food is allowed within 4 hours after dosing. During the study, subjects will receive standardized meals at approximately the same time each day.
| Study group | Role | What they receive |
|---|---|---|
| [14C]ABSK021 Suspension | Experimental | On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of [14C] ABSK021 in the fasted state. Receives: Drug: Pimicotinib（ABSK021） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)
To assess the routes and rates of elimination of ABSK021 and its metabolites after single oral administration of [14C]ABSK021 in healthy adult male subjects
Measured: All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected.
Percentage of each metabolite in urine and feces relative to the administered dose (% administered dose), or percentage of metabolites in plasma relative to total exposure AUC (% AUC);
To determine the metabolism and elimination pathways of ABSK021 after single oral administration of [14C] ABSK021 in healthy adult male subjects, and identify major metabolites.All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected.
Measured: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol
Identification of major metabolites in plasma, urine, and fecal samples
To determine the metabolism and elimination pathways of ABSK021 after single oral administration of [14C] ABSK021 in healthy adult male subjects, and identify major metabolites.All excreted urine and feces and plasma samples at specified time points during 0-504 hours after dosing will be collected.
Measured: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol
AUC 0-∞
To evaluate the pharmacokinetics of ABSK021 and its major metabolites in the urine of healthy adult male subjects after a single oral administration [14C] of ABSK021.
Measured: Conduct testing within 1 month after all subjects collect all samples at all time points required by the protocol
Tmax
To evaluate the pharmacokinetics of ABSK021 and its major metabolites in the fecal of healthy adult male subjects after a single oral administration [14C] of ABSK021
Measured: Conduct testing within 1 month after all subjects collect PK samples at all time points required by the protocol
Secondary outcomes (1)
Frequency, type and severity of adverse events/serious adverse events; changes in vital signs, 12-lead ECGs, laboratory tests, etc.
To assess the safety and tolerability of a single oral dose of approximately 50 mg with approximately 100 μCi [14C] ABSK021 in healthy adult male subjects
Measured: From signing the ICF until 22 days after the first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start13 Dec 2023
- Primary completion30 May 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Abbisko Therapeutics 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
- Not applicable
- Intervention model
- Single group
- Model description
- On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of \[14C\] ABSK021 in the fasted state.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, Professor, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186583
- Sponsor's protocol ID
- ABSK021-104
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mass Balance Study of [14C]ABSK021 in Healthy Adult Male Chinese Subjects
- ClinicalTrials.gov ID
- NCT06186583
- Acronym / sponsor ID
- ABSK021-104
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 2 Jan 2024 (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 study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK021 in healthy adult male subjects. The study plans to enroll 6 to 10 healthy male subjects to ensure at least 6 evaluable subjects.
Detailed description
Subjects will be screened within 14 days before dose administration (D-14 to D-3), and will be admitted to the trial ward two days before dose administration (D-2).
On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of [14C] ABSK021 in the fasted state.
All excreted urine and feces samples and blood samples at specified time points during 0-504 hours after dosing will be collected. Random feces within 48 hours prior to dosing and random urine within 24 hours prior to dosing will be collected as blank samples (if there are multiple blank samples, the most recent blank sample before dosing will be selected for analysis).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of [14C] ABSK021 in the fasted state.
| Arm | Type | Receives |
|---|---|---|
| [14C]ABSK021 Suspension | Experimental | Drug: Pimicotinib（ABSK021）On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of [14C] ABSK021 in the fasted state. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who fully understand the content, procedures and possible adverse reactions before the study, and voluntarily sign the informed consent form, and can complete the study in accordance with the requirements in the protocol;
- Healthy male subjects aged 18 to 45 years (including 18 and 45 years) at screening;
- Weight ≥ 50 kg, body mass index (BMI) between 19 and 28 (including 19 and 28), BMI = weight (kg)/height (m) 2;
- Subjects must have regular defecation in the past three months;
- Male subjects of childbearing potential must agree to use effective contraceptive methods during the study and within 12 months after administration of study drug . Male subjects must agree to not donate sperm during this period.
Key exclusion criteria (26 listed)
- Abnormal and clinically significant complete physical examination, vital signs, digital rectal examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, stool routine + occult blood, thyroid function, etc.), 12-lead electrocardiogram, chest X-ray (anteroposterior position), abdominal B ultrasound (hepatobiliary, pancreas, spleen and kidney);
- Abnormal and clinically significant ophthalmic examination (slit lamp, intraocular pressure and fundus photography);
- Tested positive for any one of the following: serum hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, treponema pallidum antibody (Syphilis) screening;
- The baseline of heart rate corrected QT, QTcF interval prolongs > 450ms; family history of long QT syndrome (Note: QTc interval is corrected by Fridericia formula);
- Creatinine clearance (CrCL) ≤ 60 mL/min, calculated using the Cockcroft-Gault formula ;
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 |
|---|---|---|
| Pimicotinib（ABSK021）A standard meal should be given to the subjects in the evening before dosing. Then, the subjects should fast for at least 10 hours. Water is not prohibited overnight. The next morning, the subjects should administer study drug in fasted state with warm water. The total volume of warm water and suspension is approximately 240 mL. Water is prohibited from 1 hour before dosing to 1 hour after dosing. No food is allowed within 4 hours after dosing. During the study, subjects will receive standardized meals at approximately the same time each day. | Drug | [14C]ABSK021 Suspension |
Primary outcome
Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)
Time frame: All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected.
To assess the routes and rates of elimination of ABSK021 and its metabolites after single oral administration of [14C]ABSK021 in healthy adult male subjects
Percentage of each metabolite in urine and feces relative to the administered dose (% administered dose), or percentage of metabolites in plasma relative to total exposure AUC (% AUC);
Time frame: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol
To determine the metabolism and elimination pathways of ABSK021 after single oral administration of [14C] ABSK021 in healthy adult male subjects, and identify major metabolites.All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected.
Identification of major metabolites in plasma, urine, and fecal samples
Time frame: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol
To determine the metabolism and elimination pathways of ABSK021 after single oral administration of [14C] ABSK021 in healthy adult male subjects, and identify major metabolites.All excreted urine and feces and plasma samples at specified time points during 0-504 hours after dosing will be collected.
AUC 0-∞
Time frame: Conduct testing within 1 month after all subjects collect all samples at all time points required by the protocol
To evaluate the pharmacokinetics of ABSK021 and its major metabolites in the urine of healthy adult male subjects after a single oral administration [14C] of ABSK021.
Tmax
Time frame: Conduct testing within 1 month after all subjects collect PK samples at all time points required by the protocol
To evaluate the pharmacokinetics of ABSK021 and its major metabolites in the fecal of healthy adult male subjects after a single oral administration [14C] of ABSK021
1 secondary outcome
Frequency, type and severity of adverse events/serious adverse events; changes in vital signs, 12-lead ECGs, laboratory tests, etc.
Time frame: From signing the ICF until 22 days after the first dosing
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 Aug 2024.
- Individual participant dataSharing planned: No
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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 Miao, Professor principal investigator
The 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 Pimicotinib（ABSK021） in people with Healthy Subjects, run by Abbisko Therapeutics 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 26 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 Aug 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 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?
Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces) (time frame: All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected.). 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 12 Aug 2024.