PharmacokineticsPhase 1NCT06694948
A Study to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules in Healthy Subjects
A Phase 1 study testing pimicotinib capsules in people with Pharmacokinetics, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
Trial summary
This is a study to evaluate the relative bioavailability and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition. 26 healthy subjects are planned to be enrolled and will be evenly randomized 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
- Pharmacokinetics
- What is being tested?
- pimicotinib capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 17 Jan 2025
- 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 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;
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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 Single-Center, Open-label, Randomized, Single Dose, Two-way Crossover Design to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules Under Fasting Conditions in Healthy Subjects
This is a study to evaluate the relative bioavailability and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition. 26 healthy subjects are planned to be enrolled and will be evenly randomized to either Study Sequence A or Study Sequence B . Subjects in Sequence A/Sequence B will receive a single 50 mg oral dose of test/reference pimicotinib in period 1 and cross over in period 2. Blood samples will be collected for PK analysis in totally 32 time-points.
- Conditions
- Pharmacokinetics
- Being tested
- pimicotinib capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pimicotinib capsulesDrug
pimicotinib capsules
| Study group | Role | What they receive |
|---|---|---|
| pimicotinib (test capsule-reference capsule) | Other | subjects in sequence A will receive a single oral dose of 50 mg test capsule administered as 2 x 25 mg (the capsule is commercial formulation to be marketed) in period 1 day 1 and receive a single oral dose of 50 mg reference capsule administered as 2 x 25 mg (the capsule was used in phase 3 study Part 1) in period 2 day 1. Receives: Drug: pimicotinib capsules |
| pimicotinib (reference capsule-test capsule) | Other | subjects in sequence B will receive a single oral dose of 50 mg reference capsule administered as 2 x 25 mg (the capsule was used in phase 3 study Part 1) in period 1 day 1 and receive a single oral dose of 50 mg test capsule administered as 2 x 25 mg (the capsule is commercial formulation to be marketed) in period 2 day 1 . Receives: Drug: pimicotinib capsules |
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, 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, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
AUClast
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, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
Secondary outcomes (4)
AE
To evaluate the safety following a single oral dose of the two different pimicotinib capsules under fasting conditions in healthy subjects, including Adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, electrocardiograms (ECGs), laboratory tests
Measured: through study completion, an average of 24 days
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, 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, 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, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start10 Dec 2024
- Primary completion3 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, Doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694948
- Sponsor's protocol ID
- ABSK021-108
- Status last verified
- Feb 2025
- First submitted
- 14 Nov 2024
- Last updated
- 17 Feb 2025
- 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-label, Randomized, Single Dose, Two-way Crossover Design to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules Under Fasting Conditions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06694948
- Acronym / sponsor ID
- ABSK021-108
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 19 Nov 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 is a study to evaluate the relative bioavailability and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition. 26 healthy subjects are planned to be enrolled and will be evenly randomized to either Study Sequence A or Study Sequence B . Subjects in Sequence A/Sequence B will receive a single 50 mg oral dose of test/reference pimicotinib in period 1 and cross over in period 2. Blood samples will be collected for PK analysis in totally 32 time-points.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pimicotinib (test capsule-reference capsule) | Other | Drug: pimicotinib capsulessubjects in sequence A will receive a single oral dose of 50 mg test capsule administered as 2 x 25 mg (the capsule is commercial formulation to be marketed) in period 1 day 1 and receive a single oral dose of 50 mg reference capsule administered as 2 x 25 mg (the capsule was used in phase 3 study Part 1) in period 2 day 1. |
| pimicotinib (reference capsule-test capsule) | Other | Drug: pimicotinib capsulessubjects in sequence B will receive a single oral dose of 50 mg reference capsule administered as 2 x 25 mg (the capsule was used in phase 3 study Part 1) in period 1 day 1 and receive a single oral dose of 50 mg test capsule administered as 2 x 25 mg (the capsule is commercial formulation to be marketed) in period 2 day 1 . |
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 capsulespimicotinib capsules | Drug | pimicotinib (reference capsule-test capsule), pimicotinib (test capsule-reference capsule) |
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, 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, 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.
AUClast
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 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
AE
Time frame: through study completion, an average of 24 days
t1/2
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 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, 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, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
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 17 Feb 2025.
- 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.
Yanhua Ding, Doctor 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 capsules in people with Pharmacokinetics, 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: finished, as of the sponsor's last update on 17 Feb 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?
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: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 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 17 Feb 2025.