PharmacokineticsPhase 1NCT06562946
The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function
A Phase 1 study testing Pimicotinib in people with Pharmacokinetics, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
Trial summary
This is a phase 1, open-label, parallel-group, single-center study to evaluate the pharmacokinetics and safety of a single 25 mg oral dose of pimicotinib in subjects with mild and moderate hepatic impairment and in control subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Pimicotinib
- 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
- 20 Sep 2024to 10 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects should understand the study procedures and sign the informed consent form prior to Screening.
- Subjects must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
- Weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 18 and 32 (inclusive), BMI = weight (kg)/height (m)2.
- Serum creatinine (Cr) ≤ 1.5 × ULN, or Creatinine clearance (Crcl) ≥ 60 mL/min (Cockcroft-Gault formula).
Who cannot join
- Known allergy or hypersensitivity to any components of the investigational drug product;
- Has a history of cancer in five years (malignancy), exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinomas in situ;
- Has factors that significantly affect the absorption of oral drug, such as inability to take oral medication or significant nausea and vomiting, malabsorption, external bile duct drainage, massive small bowel resection, etc.
- Has a history of portosystemic shunt.
- Participation in any clinical study of an investigational drug/device within 3 months of the drug prior to Day -1;
- Received live vaccines or live-attenuated virus vaccine within 3 months prior to screening, or plan to get vaccinated during the study;
- Previously participated in this study or any other study related to pimicotinib and received pimicotinib;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function
This is a phase 1, open-label, parallel-group, single-center study to evaluate the pharmacokinetics and safety of a single 25 mg oral dose of pimicotinib in subjects with mild and moderate hepatic impairment and in control subjects with normal hepatic function.
- Conditions
- Pharmacokinetics
- Being tested
- Pimicotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimicotinibDrug
Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.
| Study group | Role | What they receive |
|---|---|---|
| The mild (Child-Pugh score 5 to 6) hepatic impairment. | Experimental | Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites. Receives: Drug: Pimicotinib |
| The moderate (Child-Pugh score 7 to 9) hepatic impairment. | Experimental | Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites. Receives: Drug: Pimicotinib |
| The healthy subjects. | Experimental | Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites. Receives: Drug: Pimicotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.
Measured: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
AUClast
To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.
Measured: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
AUC 0-∞
To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.
Measured: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start20 Sep 2024
- Primary completion30 Dec 2024
- Study completion10 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanan Wang, Doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562946
- Sponsor's protocol ID
- ABSK021-106
- Status last verified
- Jan 2025
- First submitted
- 18 Aug 2024
- Last updated
- 20 Jan 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT06562946
- Acronym / sponsor ID
- ABSK021-106
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 20 Aug 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 phase 1, open-label, parallel-group, single-center study to evaluate the pharmacokinetics and safety of a single 25 mg oral dose of pimicotinib in subjects with mild and moderate hepatic impairment and in control subjects with normal hepatic function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The mild (Child-Pugh score 5 to 6) hepatic impairment. | Experimental | Drug: PimicotinibSubjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites. |
| The moderate (Child-Pugh score 7 to 9) hepatic impairment. | Experimental | Drug: PimicotinibSubjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites. |
| The healthy subjects. | Experimental | Drug: PimicotinibSubjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects should understand the study procedures and sign the informed consent form prior to Screening.
- Subjects must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
- Weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 18 and 32 (inclusive), BMI = weight (kg)/height (m)2.
- Serum creatinine (Cr) ≤ 1.5 × ULN, or Creatinine clearance (Crcl) ≥ 60 mL/min (Cockcroft-Gault formula).
Key exclusion criteria (7 listed)
- Known allergy or hypersensitivity to any components of the investigational drug product;
- Has a history of cancer in five years (malignancy), exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinomas in situ;
- Has factors that significantly affect the absorption of oral drug, such as inability to take oral medication or significant nausea and vomiting, malabsorption, external bile duct drainage, massive small bowel resection, etc.
- Has a history of portosystemic shunt.
- Participation in any clinical study of an investigational drug/device within 3 months of the drug prior to Day -1;
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 |
|---|---|---|
| PimicotinibPimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule. | Drug | The healthy subjects., The mild (Child-Pugh score 5 to 6) hepatic impairment., The moderate (Child-Pugh score 7 to 9) hepatic impairment. |
Primary outcome
Cmax
Time frame: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.
AUClast
Time frame: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.
AUC 0-∞
Time frame: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.
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 20 Jan 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.
Yanan Wang, 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 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 4 inclusion and 7 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 20 Jan 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: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol). 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 Jan 2025.