Healthy SubjectsPhase 1NCT06884072
A Study to Evaluate the Effect of a High-fat Meal on the Exposure of Pimicotinib Capsule in Healthy Subjects
A Phase 1 study testing Pimicotinib capsule in people with Healthy Subjects, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
Trial summary
This is a study to evaluate the impact of a high - fat meal on the exposure of Pimicotinib capsules in healthy subjects. It is planned to recruit 16 healthy subjects and randomly and equally assign them to either Study Sequence A or Study Sequence B. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Pimicotinib capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2025to 1 Aug 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 18 to 50 years (inclusive) at screening;
- Weight ≥ 50.0 kg (male) or ≥ 45.0 kg (female);
- Normal or abnormal but not clinically significant results in medical history, physical examination, clinical laboratory tests and other relevant examinations as assessed by the investigator at Screening;
- Male or female subjects of childbearing potential must agree to use effective methods of contraception during the study and within 6 months after the last dose of investigational product;
- Willing to participate in this study, understand the study procedures and sign the informed consent form prior to screening; willing to comply with the study procedures.
Who cannot join
- Past or current medical history of chronic or severe conditions in cardiovascular, respiratory, blood, liver, kidney, gastrointestinal, endocrine or nervous systems;
- Known or persistent mental disorders;
- Past history of gastric or intestinal surgery, or other operations;
- Dysphagia and inability to take the investigational product orally;
- Intolerant to venipuncture, difficult to collect blood samples, and fear of needle sickness and blood;
- Known allergy to two or more kinds of foods and drugs; or allergic to pimicotinib or its excipients;and intolerance to dairy products;
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- History of infection within 30 days prior to screening;
- Symptoms of fatigue and pyrexia within 2 weeks prior to screening;
- Abnormal laboratory tests;
- Positive result for either of the following tests: serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody, and treponema pallidum antibody;
- Participated in any clinical studies of drugs as a study subject and received the study drug within 3 months prior to screening;
- Previously participated in any other study related to pimicotinib and received pimicotinib;
- Used strong inhibitors or inducers of CYP3A4 within 14 days prior to screening and at Screening or intending to use during the study;
- Have special diet requirements and cannot accept to take a unified dietary;
- Consumption of more than 14 units of alcohol per week within 3 months prior to signing the informed consent form, or a positive result for alcohol breath test on the day pre-dose, or unable to abstain from alcohol during the study;
- Consumption of more than 5 cigarettes per day within 3 months prior to signing the informed consent form, or unable to abstain from tobacco products during the study;
- Previous chronic consumption of excessive amount of tea, coffee, or caffeinated beverages or unable to abstain from caffeinated beverages during the study;
- Known history of drug abuse or positive for drug abuse screening test;
- Used over the counter or prescription drugs within 14 days prior to screening, or plan to use such drugs during the study;
- Donated or lost > 400 mL of blood within 3 months prior to screening; received blood transfusions or used blood products within 2 months prior to screening;
- Received vaccine within 2 months prior to screening, or plan to get vaccinated during the study;
- Significant abnormalities and judged by the investigator as clinical significance in vital signs;
- Heart rate-corrected QT interval prolongation;
- Subjects involved in the design or conduct of this study and their immediate family members;
- Subjects who, in the opinion of the investigator, are not suitable for enrollment or may not be able to complete the study for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, Single Dose, 2-Treatment, 2-Sequence, 2-Period Crossover Study to Evaluate the Effect of a High-fat Meal on the Exposures of Pimicotinib Capsule in Healthy Subjects
This is a study to evaluate the impact of a high - fat meal on the exposure of Pimicotinib capsules in healthy subjects. It is planned to recruit 16 healthy subjects and randomly and equally assign them to either Study Sequence A or Study Sequence B. Subjects in Sequence A will take a single 50 - milligram oral dose of Pimicotinib capsules in a post - high - fat - meal state during Phase 1. Subjects in Sequence B will take a single 50 - milligram oral dose of Pimicotinib capsules in a fasting state during Phase 1 and then receive cross - over administration in Phase 2. In total, blood samples will be collected at 34 time points for pharmacokinetic (PK) analysis.
- Conditions
- Healthy Subjects
- Being tested
- Pimicotinib capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimicotinib capsuleDrug
Pimicotinib capsule
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Pimicotinib 50mg (2x25mg) - High - fat Meal First, Then Fasting | Experimental | Subjects in Sequence A will be administered a single oral dose of 50 mg Pimicotinib capsules (2 x 25 mg) in a post-high-fat meal state on Day 1 of Period 1, and a single oral dose of 50 mg Pimicotinib capsules (2 x 25 mg) in a fasting state on Day 1 of Period 2. Receives: Drug: Pimicotinib capsule |
| Sequence B: Pimicotinib 50mg (2x25mg) - Fasting First, Then High - fat Meal | Experimental | Subjects in Sequence B will receive a single oral dose of 50 mg pimicotinib capsules (2 x 25 mg) in a fasting state on Day 1 of Period 1, and a single oral dose of 50 mg pimicotinib capsules (2 x 25 mg) in a post-high-fat meal state on Day 1 of Period 2. Receives: Drug: Pimicotinib capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak concentration, the maximum observed plasma concentration of pimicotinib
Measured: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
AUC0-∞
Area under the plasma concentration-time curve of pimicotinib from time 0 to infinity, calculated as: AUC0-∞=AUClast +Clast/λz; Clast refers to the last measurable (non-BQL) plasma concentration of pimicotinib.
Measured: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
AUC last
Area under the plasma concentration-time curve of pimicotinib from time 0 to the time of last measurable (non-BQL) concentration (calculated using the Linear Up Log Down trapezoidal method)
Measured: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
Secondary outcomes (4)
t1/2
Elimination half-life
Measured: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
CL/F
Total apparent clearance after a single oral dose
Measured: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
Vz/F
Apparent volume of distribution after a single oral dose
Measured: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
AE
To evaluate the safety of a single oral administration of pimicotinib capsules in healthy subjects. The evaluation contents include adverse events (AE), serious adverse events (SAE), vital signs, physical examinations, electrocardiograms (ECG), and laboratory tests.
Measured: through study completion, an average of 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start8 Apr 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaojiao Li, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884072
- Sponsor's protocol ID
- ABSK021-111
- Status last verified
- Apr 2025
- First submitted
- 13 Mar 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Single Dose, 2-Treatment, 2-Sequence, 2-Period Crossover Study to Evaluate the Effect of a High-fat Meal on the Exposures of Pimicotinib Capsule in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06884072
- Acronym / sponsor ID
- ABSK021-111
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 19 Mar 2025 (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 a study to evaluate the impact of a high - fat meal on the exposure of Pimicotinib capsules in healthy subjects. It is planned to recruit 16 healthy subjects and randomly and equally assign them to either Study Sequence A or Study Sequence B. Subjects in Sequence A will take a single 50 - milligram oral dose of Pimicotinib capsules in a post - high - fat - meal state during Phase 1. Subjects in Sequence B will take a single 50 - milligram oral dose of Pimicotinib capsules in a fasting state during Phase 1 and then receive cross - over administration in Phase 2. In total, blood samples will be collected at 34 time points for pharmacokinetic (PK) analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Pimicotinib 50mg (2x25mg) - High - fat Meal First, Then Fasting | Experimental | Drug: Pimicotinib capsuleSubjects in Sequence A will be administered a single oral dose of 50 mg Pimicotinib capsules (2 x 25 mg) in a post-high-fat meal state on Day 1 of Period 1, and a single oral dose of 50 mg Pimicotinib capsules (2 x 25 mg) in a fasting state on Day 1 of Period 2. |
| Sequence B: Pimicotinib 50mg (2x25mg) - Fasting First, Then High - fat Meal | Experimental | Drug: Pimicotinib capsuleSubjects in Sequence B will receive a single oral dose of 50 mg pimicotinib capsules (2 x 25 mg) in a fasting state on Day 1 of Period 1, and a single oral dose of 50 mg pimicotinib capsules (2 x 25 mg) in a post-high-fat meal state on Day 1 of Period 2. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects aged 18 to 50 years (inclusive) at screening;
- Weight ≥ 50.0 kg (male) or ≥ 45.0 kg (female);
- Normal or abnormal but not clinically significant results in medical history, physical examination, clinical laboratory tests and other relevant examinations as assessed by the investigator at Screening;
- Male or female subjects of childbearing potential must agree to use effective methods of contraception during the study and within 6 months after the last dose of investigational product;
- Willing to participate in this study, understand the study procedures and sign the informed consent form prior to screening; willing to comply with the study procedures.
Key exclusion criteria (25 listed)
- Past or current medical history of chronic or severe conditions in cardiovascular, respiratory, blood, liver, kidney, gastrointestinal, endocrine or nervous systems;
- Known or persistent mental disorders;
- Past history of gastric or intestinal surgery, or other operations;
- Dysphagia and inability to take the investigational product orally;
- Intolerant to venipuncture, difficult to collect blood samples, and fear of needle sickness and blood;
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 capsulePimicotinib capsule | Drug | Sequence A: Pimicotinib 50mg (2x25mg) - High - fat Meal First, Then Fasting, Sequence B: Pimicotinib 50mg (2x25mg) - Fasting First, Then High - fat Meal |
Primary outcome
Cmax
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
Peak concentration, the maximum observed plasma concentration of pimicotinib
AUC0-∞
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
Area under the plasma concentration-time curve of pimicotinib from time 0 to infinity, calculated as: AUC0-∞=AUClast +Clast/λz; Clast refers to the last measurable (non-BQL) plasma concentration of pimicotinib.
AUC last
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
Area under the plasma concentration-time curve of pimicotinib from time 0 to the time of last measurable (non-BQL) concentration (calculated using the Linear Up Log Down trapezoidal method)
4 secondary outcomes
t1/2
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
CL/F
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
Vz/F
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
AE
Time frame: through study completion, an average of 26 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
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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.
Xiaojiao Li principal investigator
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 Pimicotinib capsule 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 25 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 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 20 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.