Hepatic ImpairmentPhase 1NCT05684653
Study to Evaluate Orelabrutinib Tablets in Subjects With Hepatic Impairment and Healthy Subject
A Phase 1 study testing Orelabrutinib Tablets in people with Hepatic Impairment, run by Beijing InnoCare Pharma Tech Co., Ltd. at 4 sites in China.
Trial summary
This is an Open-Label, Parallel, Single-dose, Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Orelabrutinib Tablets in Subjects with Varying Degrees of Hepatic Impairment Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Orelabrutinib Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesChina
- Study dates
- 17 Mar 2023to 30 Dec 2023
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject understands and has provided the informed consent form (ICF);
- Male and female between 18 and 79 years old (inclusive) at the time of signing the ICF;
- Male with weight not less than 50 kg and female not less than 45 kg. Body mass index (BMI): 18-32 kg/m2 (inclusive);
- The subject is suitable to participate in the study as evaluated by the investigator based on physical examination, vital signs, laboratory tests, and 12-lead ECG;
- Within 2 weeks before the study medication, the subject took no prohibited drug (see Appendix 4 for the contraindicated drugs), including any prescription drug, OTC drug, Chinese herbal medicine, or dietary supplement;
- The subject is willing to take effective contraception voluntarily from the screening to 3 months after the dosing of study drug;
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- The following criteria apply to the subjects with hepatic impairment:
- Patients with chronic hepatic impairment resulted from viral hepatitis, alcoholic liver disease, autoimmune hepatitis, or other causes. Patients with chronic hepatic impairment are defined as patients with a history of hepatic impairment and stable liver functions for ≥ 1 month based on clinical manifestations. For patients with viral hepatitis, it is imperative to exclude active hepatitis C (if the patient was tested HCV antibody positive, at least 2 tests within 3 months indicating HCV-RNA negative are required) and active hepatitis B (HBV-DNA level should be less than 100 IU/mL with concurrent antiviral treatment); or patients with hepatic cirrhosis confirmed by liver biopsy or other medical imaging (including laparoscopy, computed tomography (CT), magnetic resonance imaging (MRI), or ultrasonography); or patients with diagnosed hepatic cirrhosis complicated with portal hypertension (allow receiving related portal hypotensives treatments, e.g., carvedilol). Patients who meet any of the above conditions can participate in this study.
- 8. Hepatic impairment of Class A or Class B or Class C based on Child-Pugh system (no albumin should be used within 14 days); and resulted from prior primary liver disease; 9. Coagulation functions: INR≤2.5 without intervention of coagulants (2-week washout); hematology: neutrophil count ≥ 1.5 × 109/L, hemoglobin ≥ 70 g/L, platelet count ≥30 × 109/L; hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × upper limit of normal (ULN); 10. Stable therapy for hepatic impairment before the study medication, and at least 4-week stable medication for treatment of hepatic impairment (stable medications were judged by the investigator); 11. The subject agrees to abstain from smoking, alcohol, caffeinated beverages, and fruit juice beverages from 7 days before the study medication to the end of study follow-up.
Who cannot join
- Drug-induced liver injury;
- Acute hepatic impairment due to various causes;
- Any of the following circumstances: liver transplant recipients; acute or exacerbating hepatic impairment due to various causes; liver failure, complicated with grade 3/4 hepatic encephalopathy; active lesions of hepatic cancer; esophageal and gastric varices hemorrhage; serious/advanced peritoneal or pleural effusion requiring puncture drainage and albumin supplementation; situations deemed not suitable to participate in the study including hepatorenal syndrome;
- Diseases influencing bile excretion within 3 months before the screening, including cholestatic liver disease or biliary tract infection;
- Subjects having portal hypertension with esophageal and gastric varices bleeding within 3 months or subjects having received portal-systemic shunt procedure within half a year, including transjugular intrahepatic portosystemic shunt (TIPS);
- History of significant allergy or intolerance to any drug, food, or other substance;
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- Patients with abnormal test value which is clinical significance at screening or before enrollment, that influence the evaluation of safety, including physical examination, vital signs, routine laboratory tests (hematology, blood biochemistry, coagulation function, and urinalysis), 12-lead ECG, and chest CT;
- Any history of serious disease or tother conditions that may influence the study findings, including but not limited to disorders of nervous, cardiovascular, hematologic and lymphatic, immune, renal, gastrointestinal, respiratory, endocrine systems;
- History of surgery that may influence drug absorption, distribution, metabolism, or excretion (e.g., gastroduodenectomy), or proposed possible surgery or scheduled hospitalization during the study;
- Clinical manifestations of bacterial, viral, parasitic, or fungal infection requiring treatment, and coronavirus infection or nucleic acid test positive at screening (excluding hepatitis B) or history of serious active infection within 1 month before the screening;
- Human immune-deficiency virus (HIV) antibody positive or active syphilis at screening;
- Anticoagulation therapies including warfarin or thrombin inhibitors and/or antiplatelet therapy with aspirin within 1 month before the screening;
- Administration of inhibitors or inducers of drug metabolism in the liver, administration of sensitive P-gp and BCRP substrates with narrow therapeutic index within 2 weeks (or 5 half-lives, whichever longer) before the screening;
- Drug abuse or history of soft drugs within 3 months before the screening or history of hard drugs within 1 year before the screening; or urine drug test positive at screening;
- Mean daily consumption of more than 5 cigarettes or habitually consumption of nicotine-containing products , mean daily alcohol intake exceeds the criteria within 3 months before the screening with failure to abstain from smoking or or cannot abstain from alcohol during the trial;
- Intake of grapefruit juice, methylxanthine-rich food or beverages (e.g., coffee, tea, cola, chocolates, and energy drinks) within 7 days before taking the study medication, or strenuous exercise or any other factor influencing drug absorption, distribution, metabolism, and excretion, with failure to abstain from during the trial;
- Those who participated in clinical trials of any other study drug or medical device within 3 months before the first dose of the study drug, or participated in 3 or more clinical trials of drugs or medical devices within the latest year; for other study drugs with a long half-life, a longer time interval is required for at least 5 half-lives of the drug;
- Blood donation (or lost) ≥ 400 mL within 3 months before the screening, or blood transfusion recipients or blood product users;
- Vaccination within 4 weeks before the screening or scheduled vaccination during the trial;
- Women in lactation or with serum pregnancy test positive at screening;
- Birth plan scheduled from screening to 3 months after trial completion, or unwilling to take rigorous contraception from screening to 3 months after study completion, or proposed scheduled sperm donation;
- Unwilling or Unable to abide by the study procedure specified in the protocol, or has any factor deemed unsuitable for participating in this clinical study by the investigator.
- The following exclusion criteria apply to subjects with normal hepatic function:
- History of hepatic impairment, or presence of possible hepatic impairment at screening as suggested by physical examination and laboratory tests; HBsAg-positive or anti-HCV antibody-positive.
Trial locations and contacts
4 sites in 1 country.
Weifeng Zhao contact
China4 sites, 4 recruiting
- Not yet recruiting
The First Affilitaed Hospital of Bengbu Medical College
Bengbu, Anhui
Huan Zhou
Yu Zhu
- Recruiting
Deyang People's Hospital
Deyang, Sichuan
Lianlian Fan
Shunbin Ding
- Not yet recruiting
Shulan (Hangzhou) hospital
Hangzhou, Zhejiang
Lihua Wu
Hainv Gao
- Recruiting
The First Affilitaed Hospital of Soochow University
Suzhou, Jiangsu
Liyan Miao
Weifeng Zhao
About this study
Official title: An Open-Label, Parallel, Single-dose, Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Orelabrutinib Tablets in Subjects With Varying Degrees of Hepatic Impairment
This is an Open-Label, Parallel, Single-dose, Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Orelabrutinib Tablets in Subjects with Varying Degrees of Hepatic Impairment
- Conditions
- Hepatic Impairment
- Being tested
- Orelabrutinib Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib TabletsDrug
50 mg, single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib Tablets | Experimental | Subjects take Single dose of 50 mg orelabrutinib tablet under fasting state Receives: Drug: Orelabrutinib Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) (Blood)
Measured: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Area under the concentration-time curve from time 0 to infinity (AUC0-t) (Blood)
Measured: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose , at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Maximum concentration(Cmax) (Blood)
Measured: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Secondary outcomes (8)
Time to maximum concentration（Tmax）(Blood)
Measured: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Half-Life (T1/2) (Blood)
Measured: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Apparent Volume of Distribution (Vz/F) (Blood)
Measured: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Apparent clearance (CL/F) (Blood)
Measured: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Unbound maximum concentration (Cmax, unb) (Blood)
Measured: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Area under the unbound drug concentration-time curve (AUCunb) (Blood)
Measured: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48hours post dose.
AEs
Measured: Through study completion, an average of 1 year
SAEs
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start17 Mar 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The 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
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684653
- Sponsor's protocol ID
- ICP-CL-00119
- Status last verified
- Sep 2023
- First submitted
- 14 Dec 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Parallel, Single-dose, Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Orelabrutinib Tablets in Subjects With Varying Degrees of Hepatic Impairment
- ClinicalTrials.gov ID
- NCT05684653
- Acronym / sponsor ID
- ICP-CL-00119
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Jan 2023 (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 an Open-Label, Parallel, Single-dose, Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Orelabrutinib Tablets in Subjects with Varying Degrees of Hepatic Impairment
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib Tablets | Experimental | Drug: Orelabrutinib TabletsSubjects take Single dose of 50 mg orelabrutinib tablet under fasting state |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject understands and has provided the informed consent form (ICF);
- Male and female between 18 and 79 years old (inclusive) at the time of signing the ICF;
- Male with weight not less than 50 kg and female not less than 45 kg. Body mass index (BMI): 18-32 kg/m2 (inclusive);
- The subject is suitable to participate in the study as evaluated by the investigator based on physical examination, vital signs, laboratory tests, and 12-lead ECG;
- Within 2 weeks before the study medication, the subject took no prohibited drug (see Appendix 4 for the contraindicated drugs), including any prescription drug, OTC drug, Chinese herbal medicine, or dietary supplement;
Key exclusion criteria (24 listed)
- Drug-induced liver injury;
- Acute hepatic impairment due to various causes;
- Any of the following circumstances: liver transplant recipients; acute or exacerbating hepatic impairment due to various causes; liver failure, complicated with grade 3/4 hepatic encephalopathy; active lesions of hepatic cancer; esophageal and gastric varices hemorrhage; serious/advanced peritoneal or pleural effusion requiring puncture drainage and albumin supplementation; situations deemed not suitable to participate in the study including hepatorenal syndrome;
- Diseases influencing bile excretion within 3 months before the screening, including cholestatic liver disease or biliary tract infection;
- Subjects having portal hypertension with esophageal and gastric varices bleeding within 3 months or subjects having received portal-systemic shunt procedure within half a year, including transjugular intrahepatic portosystemic shunt (TIPS);
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 |
|---|---|---|
| Orelabrutinib Tablets50 mg, single oral dose | Drug | Orelabrutinib Tablets |
Primary outcome
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) (Blood)
Time frame: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Area under the concentration-time curve from time 0 to infinity (AUC0-t) (Blood)
Time frame: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose , at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Maximum concentration(Cmax) (Blood)
Time frame: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
8 secondary outcomes
Time to maximum concentration（Tmax）(Blood)
Time frame: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Half-Life (T1/2) (Blood)
Time frame: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Apparent Volume of Distribution (Vz/F) (Blood)
Time frame: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Apparent clearance (CL/F) (Blood)
Time frame: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Unbound maximum concentration (Cmax, unb) (Blood)
Time frame: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.
Area under the unbound drug concentration-time curve (AUCunb) (Blood)
Time frame: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48hours post dose.
AEs
Time frame: Through study completion, an average of 1 year
SAEs
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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.
Weifeng Zhao contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Orelabrutinib Tablets in people with Hepatic Impairment, run by Beijing InnoCare Pharma Tech Co., Ltd. at 4 sites 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 9 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liyan Miao (86-512-67972858, Sdfyy8040@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) (Blood) (time frame: Blood samples for pharmacokinetics will be taken on Day 1 at pre dose, at 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose.). 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 21 Sep 2023.