Healthy SubjectsPhase 1NCT06779253
A Study to Investigate The Effect of Pimicotinib on The Pharmacokinetics of Metformin, Fexofenadine and Rosuvastatin In Healthy Subjects
A Phase 1 study testing pimicotinib capsules in people with Healthy Subjects, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
Trial summary
This is a an open-label, fixed-sequence DDI study conducted in Chinese healthy subjects to investigate the effect of multiple oral doses of pimicotinib on the pharmacokinetics of fexofenadine , rosuvastatin and metformin . 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 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2025to 22 May 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 and at least 25% of each sex should be included.
- Weight ≥ 50.0 kg (male) or ≥ 45.0 kg (female), with a body mass index (BMI) between 18.0 and 28.0 (inclusive), BMI = weight (kg)/height (m)2;
- Normal or abnormal but not clinically significant results in 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, and male subjects should not donate sperm during such period; female subjects should not donate ovum during such period and should not be pregnant or lactating. Pregnancy period is defined as the period from the date of conception until termination of pregnancy, and will be determined by laboratory test of human chorionic gonadotropin (hCG) during medical examination and baseline prior to initiation of the study;
- 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 that may preclude the participant from participation in the study, as determined by the investigator;
- Past history of gastric or intestinal surgery, or other operations (except for appendectomy) affecting the drug absorption;
- Dysphagia or inability to take the investigational product orally;
- Intolerant to venipuncture, difficult to collect blood samples, or fear of needle sickness and blood;
- Known allergy to two or more kinds of foods and drugs; or allergic to fexofenadine, rosuvastatin, metformin or pimicotinib or its excipients (lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide); and prone to allergic reactions such as rash and urticaria;
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- History of bacterial, fungal, parasitic, viral (excluding nasopharyngitis), mycobacterial infection, and COVID-19 infection within 30 days prior to screening; or abnormal chest X-ray finding, assessed as clinically significant (by the investigator);
- 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 participant 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(including grapefruit juice, grapefruit hybrids, punica granatum, carambola, citrus maxima, and Seville oranges) and transporter P-gp/BCRP/MATE1/OATP1B1/OATP1B3/MATE2-K/OCT2 inhibitors within 14 days prior to screening and at Screening or intending to use during the study;
- Have special dietary requirements or cannot accept to take a unified diet; specific dietary requirements: the subjects can only eat the food provided by the study site during hospitalization;
- Consumption of more than 14 units of alcohol per week (1 unit of alcohol = about 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 3 months prior to signing the informed consent form, or a positive result for alcohol breath test on the day pre-dose (breath alcohol content > 0.0 mg/100 mL), 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 (excessive intake is defined as taking more than 6 units of caffeine per day, 1 unit of caffeine equivalent to 177 mL of coffee, 355 mL of tea, 355 mL of cola, or 85 g of chocolate) or unable to abstain from caffeinated beverages during the study;
- Known history of drug abuse or positive for drug abuse screening test (morphine, methamphetamine, ketamine, methylene dioxyamphetamine, and tetrahydrocannabinol acid);
- Used over the counter or prescription drugs, including herbal medicine, health products, vitamins, and dietary supplements, 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 (including COVID-19 vaccine) within 2 months prior to screening, or plan to get vaccinated during the study;
- Abnormalities in vital signs (only one retest was allowed), including: ear temperature > 37.2 ℃; pulse rate > 100 beats/min or < 55 beats/min; systolic blood pressure ≥ 140 mmHg or < 90 mmHg, diastolic blood pressure ≥ 90 mmHg or <60 mmHg;
- Heart rate-corrected QT interval prolongation, QTcF > 450 ms for males (> 470 ms for females) (Note: QTc interval corrected using the Fridericia formula), or family history of long QT syndrome, or other clinically significant ECG abnormalities at Screening;
- 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.
China1 site
The First Affiliated Hospital Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, 250014
About this study
Official title: An Open-label, Fixed-Sequence Study to Investigate The Effect of Multiple Oral Doses of Pimicotinib on The Pharmacokinetics of Metformin, Fexofenadine and Rosuvastatin In Healthy Subjects
This is a an open-label, fixed-sequence DDI study conducted in Chinese healthy subjects to investigate the effect of multiple oral doses of pimicotinib on the pharmacokinetics of fexofenadine , rosuvastatin and metformin . Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration.
Approximately 38 healthy subjects will be enrolled to achieve 28 evaluable healthy subjects complete the study.
Blood samples will be collected for PK analysis .
- Conditions
- Healthy Subjects
- 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
the effect of multiple oral doses of pimicotinib (50 mg QD) on the pharmacokinetics of fexofenadine (P-gp sensitive substrate), rosuvastatin (BCRP sensitive substrate) and metformin (MATE1 sensitive substrate). Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration
| Study group | Role | What they receive |
|---|---|---|
| Pimicotinib with Metformin, Fexofenadine and Rosuvastatin | Other | Multiple oral doses of pimicotinib (50 mg QD) on the pharmacokinetics of fexofenadine (P-gp sensitive substrate), rosuvastatin (BCRP sensitive substrate) and metformin (MATE1 sensitive substrate). Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration.All subjects will receive the following study interventions:Day 1: metformin, Day 3: cocktail, Day 8 to 13: pimicotinib once daily (QD), Day 14: metformin + pimicotinib, Day 15: pimicotinib, Day 16: cocktail + pimicotinib, Day 17 to 20: pimicotinib QD 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 metformin, fexofenadine and rosuvastatin
Measured: pre-dose, post-dose 0.5 hour, 1 hour, 1.5hours,2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours
AUClast
Area under the plasma concentration-time curve from time 0 to the time of last measurable concentration
Measured: pre-dose, post-dose 0.5 hour, 1 hour, 1.5hours,2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours
AUC0-∞
Area under the plasma concentration-time curve from time 0 to infinity
Measured: pre-dose, post-dose 0.5 hour, 1 hour, 1.5hours,2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours
Secondary outcomes (1)
AE
Safety profile of pimicotinib in combination with metformin, fexofenadine and rosuvastatin including but not limited to Adverse events (AEs),
Measured: through study completion, an average of 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start14 Mar 2025
- Primary completion4 Apr 2025
- Study completion22 May 2025
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
- Not applicable
- Intervention model
- Single group
- Model description
- Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration. All subjects will receive the following study interventions:Day 1: metformin； Day 3: cocktail；Day 8 to 13: pimicotinib once daily (QD)；Day 14: metformin + pimicotinib；Day 15: pimicotinib，Day 16: cocktail + pimicotinib，Day 17 to 20: pimicotinib QD
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Zhao, Doctor, Principal investigator, The First Affiliated Hospital Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779253
- Sponsor's protocol ID
- ABSK021-110
- Status last verified
- Jun 2025
- First submitted
- 9 Jan 2025
- Last updated
- 26 Jun 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-Sequence Study to Investigate The Effect of Multiple Oral Doses of Pimicotinib on The Pharmacokinetics of Metformin, Fexofenadine and Rosuvastatin In Healthy Subjects
- ClinicalTrials.gov ID
- NCT06779253
- Acronym / sponsor ID
- ABSK021-110
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 16 Jan 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 an open-label, fixed-sequence DDI study conducted in Chinese healthy subjects to investigate the effect of multiple oral doses of pimicotinib on the pharmacokinetics of fexofenadine , rosuvastatin and metformin . Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration.
Approximately 38 healthy subjects will be enrolled to achieve 28 evaluable healthy subjects complete the study.
Blood samples will be collected for PK analysis .
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration. All subjects will receive the following study interventions:Day 1: metformin； Day 3: cocktail；Day 8 to 13: pimicotinib once daily (QD)；Day 14: metformin + pimicotinib；Day 15: pimicotinib，Day 16: cocktail + pimicotinib，Day 17 to 20: pimicotinib QD
| Arm | Type | Receives |
|---|---|---|
| Pimicotinib with Metformin, Fexofenadine and Rosuvastatin | Other | Drug: pimicotinib capsulesMultiple oral doses of pimicotinib (50 mg QD) on the pharmacokinetics of fexofenadine (P-gp sensitive substrate), rosuvastatin (BCRP sensitive substrate) and metformin (MATE1 sensitive substrate). Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration.All subjects will receive the following study interventions:Day 1: metformin, Day 3: cocktail, Day 8 to 13: pimicotinib once daily (QD), Day 14: metformin + pimicotinib, Day 15: pimicotinib, Day 16: cocktail + pimicotinib, Day 17 to 20: pimicotinib QD |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy subjects aged 18 to 50 years (inclusive) at screening and at least 25% of each sex should be included.
- Weight ≥ 50.0 kg (male) or ≥ 45.0 kg (female), with a body mass index (BMI) between 18.0 and 28.0 (inclusive), BMI = weight (kg)/height (m)2;
- Normal or abnormal but not clinically significant results in 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, and male subjects should not donate sperm during such period; female subjects should not donate ovum during such period and should not be pregnant or lactating. Pregnancy period is defined as the period from the date of conception until termination of pregnancy, and will be determined by laboratory test of human chorionic gonadotropin (hCG) during medical examination and baseline prior to initiation of the study;
- 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 that may preclude the participant from participation in the study, as determined by the investigator;
- Past history of gastric or intestinal surgery, or other operations (except for appendectomy) affecting the drug absorption;
- Dysphagia or inability to take the investigational product orally;
- Intolerant to venipuncture, difficult to collect blood samples, or 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 capsulesthe effect of multiple oral doses of pimicotinib (50 mg QD) on the pharmacokinetics of fexofenadine (P-gp sensitive substrate), rosuvastatin (BCRP sensitive substrate) and metformin (MATE1 sensitive substrate). Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration | Drug | Pimicotinib with Metformin, Fexofenadine and Rosuvastatin |
Primary outcome
Cmax
Time frame: pre-dose, post-dose 0.5 hour, 1 hour, 1.5hours,2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours
Peak concentration, the maximum observed plasma concentration of metformin, fexofenadine and rosuvastatin
AUClast
Time frame: pre-dose, post-dose 0.5 hour, 1 hour, 1.5hours,2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours
Area under the plasma concentration-time curve from time 0 to the time of last measurable concentration
AUC0-∞
Time frame: pre-dose, post-dose 0.5 hour, 1 hour, 1.5hours,2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours
Area under the plasma concentration-time curve from time 0 to infinity
1 secondary outcome
AE
Time frame: through study completion, an average of 50 days
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 26 Jun 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.
Wei Zhao, Doctor principal investigator
The First Affiliated Hospital Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
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 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 6 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 26 Jun 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: pre-dose, post-dose 0.5 hour, 1 hour, 1.5hours,2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 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 26 Jun 2025.