Clinical PharmacologyPhase 1NCT07374224
A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet
A Phase 1 study testing Rocbrutinib tablets, Itraconazole capsules and Rifampicin capsules in people with Clinical Pharmacology, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 1 site in China.
Trial summary
This is a phase I, open-label, two-part, fixed-sequence drug interaction study conducted to evaluate the effects of concomitant use of the potent CYP3A4 inhibitor itraconazole or the CYP3A4 inducer rifampin on the pharmacokinetics of Rocbrutinib in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Pharmacology
- What is being tested?
- Rocbrutinib tablets, Itraconazole capsules and Rifampicin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2026to 30 Aug 2026
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects had no history of serious digestive system (such as inflammatory bowel disease, chronic diarrhea, Crohn's disease, autonomic dysfunction affecting gastric emptying), nervous system, cardiovascular system, genitourinary system, respiratory system, metabolic and endocrine system, musculoskeletal system, hematologic system diseases, or tumors
- Subjects must agree to complete abstinence or use effective physical contraception (including sterilization, intrauterine device or barrier contraception) from the time of signing the informed consent form until 90 days after the last dose of medication, and have no plans to donate sperm or eggs during this period; if female subjects are using hormonal contraceptives, they must stop using them >14 days before the first dose and use at least one of the above contraceptive methods.
- Must be between 18 and 45 years old (inclusive) and be male or female when signing the informed consent form.
- Males weighing ≥50.0 kg or females weighing ≥45.0 kg, with a Body Mass Index (BMI) between 18.0 and 28.0 kg/m² (inclusive). BMI = weight (kg) / height² (m²).
- Able to understand and comply with the requirements of the research plan.
- Voluntarily participate in this study and sign the informed consent form.
Who cannot join
- Abnormalities in screening tests, such as vital signs, physical examination, or laboratory tests are clinically significant and may increase the risk of participants participating in the study or affect the scientific validity of the study.
- Abnormal electrocardiogram or myocardial enzyme levels that are clinically significant as determined by a clinician include, but are not limited to: QTcF ≥ 450 ms (corrected using the Fridricia formula, QTcF = QT/RR1/3, RR = 60/HR), etc.
- The test results for at least one of the following are positive: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, and syphilis-specific antibody.
- Patients who have taken the investigational drug within 4 weeks prior to or are required to take any drugs known to alter liver enzyme activity during the study period.
- The patient must have used any systemic medications (including any vaccines, prescription drugs, over-the-counter drugs, and traditional Chinese medicines), special medical purpose foods, or health supplements within two weeks prior to taking the investigational drug.
- Had consumed foods known to alter liver enzyme activity (such as grapefruit, star fruit, dragon fruit, and their fruit juices) and tobacco (including e-cigarettes) within one week prior to taking the investigational drug.
Show all 18Show fewer
- Consume any food or beverage containing caffeine, tea, alcohol, or xanthine within 24 hours prior to taking the investigational drug.
- Difficulty swallowing or any condition that affects drug absorption, distribution, metabolism, or excretion.
- Women with childbearing potential who have a positive pregnancy test result or who are currently breastfeeding.
- Those with a history of smoking (smoking more than 5 cigarettes/day within 3 months prior to screening) or who tested positive for nicotine screening.
- Those with a history of alcohol abuse (consuming more than 14 drinks per week, each drink equivalent to 360 ml of beer, 150 ml of wine, or 50 ml of spirits), or those who test positive for alcohol in a breathalyzer test.
- Those with a history of drug abuse/use, or who test positive in drug abuse screening.
- Those with a known history of any allergic reaction requiring medication (including allergic reactions to drugs or food) or who have an allergic disease.
- Individuals who have donated blood or lost ≥400 ml of blood within the three months prior to screening, or those who plan to donate blood during the study period and within three months after its completion, will be considered.
- Those who have undergone surgery within the past 6 months or are expected to require surgery or hospitalization during the study period will be screened.
- Candidates who have participated in other drug or medical device clinical trials within the three months prior to screening, or who plan to participate in other drug or medical device clinical trials during the study period, are eligible to be screened.
- Subjects with special dietary requirements or who are expected to be unable to comply with the research center's dietary requirements during their hospitalization
- The researchers believe that there are other circumstances that make the participants unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100070
Dongyang Prof. Liu, PhD, +8618610966092, liudongyang@vip.sina.com
Fangfang Dr. Wang, MD, +8601082266226, doctorfancy@126.com
About this study
Official title: A Phase I, Open-label, Two-part, Fixed-sequence Drug Interaction Study to Evaluate the Effects of Concomitant Use of the CYP3A4 Inhibitor Itraconazole or the CYP3A4 Inducer Rifampin on the Pharmacokinetics of Rocbrutinib in Healthy Subjects
This is a phase I, open-label, two-part, fixed-sequence drug interaction study conducted to evaluate the effects of concomitant use of the potent CYP3A4 inhibitor itraconazole or the CYP3A4 inducer rifampin on the pharmacokinetics of Rocbrutinib in healthy subjects.
Read the detailed description
This study evaluated the changes in the pharmacokinetic profiles of Rocbrutinib under maximal CYP3A inhibition and induction conditions by investigating the co-administration of Rocbrutinib with potent CYP3A inhibitors or inducers at steady state, compared with Rocbrutinib administered alone.
To assess the potential clinical inhibition of OATP1B by Rocbrutinib, blank plasma samples were collected prior to Rocbrutinib administration and 24-hour plasma samples were collected post-administration. The concentration of coproporphyrin I (CP-I) in these samples was detected and analyzed.
Furthermore, the effect of P-gp inhibitors on the drug absorption of Rocbrutinib (when acting as a substrate) was evaluated by investigating two scenarios: co-administration of a single dose of Rocbrutinib with a single dose of the P-gp inhibitor rifampicin, and co-administration of a single dose of Rocbrutinib with the P-gp inhibitor itraconazole at steady state.
- Conditions
- Clinical Pharmacology
- Being tested
- Rocbrutinib tablets, Itraconazole capsules, Rifampicin capsules
- Keywords
- drug interaction, Rocbrutinib, LP-168, CYP3A4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocbrutinib tabletsDrug
Dosage form: tablets Specification: 100 mg Dosage and administration: 100mg or 200mg, single dose, taken on the designated day according to the treatment plan.
Dosage schedule: Depending on the cohort, subjects will need to take Rocbrutinib 2 times (inhibitor cohort) or 3 times (inducer cohort) during the study period.
Itraconazole capsulesDrug
Dosage form: Capsules Specifications: 0.1g Dosage and administration: Take 400 mg (4*100 mg capsules) on Day 5, followed by 200 mg (2 100 mg capsules) once daily (QD) from Day 6 to Day 12.
Duration of medication: The medication was administered for a total of 8 days during the study period.
Rifampicin capsulesDrug
Dosage form: Capsules Specifications: 0.15g Dosage and administration: Day 4-Day 12, take 600 mg (4 150 mg capsules) once daily (QD).
Duration of medication: The medication was administered for a total of 9 days during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Inhibitor Group | Experimental | The Inhibitor Group was designed to investigate the drug-drug interaction between Rocbrutinib and itraconazole (a potent CYP3A inhibitor and P-gp inhibitor). Itraconazole is a recommended potent index CYP3A inhibitor for clinical studies in the ICH-M12 Guideline on Drug Interactions. In accordance with the recommendations in an industry white paper (CPT Pharmacometrics Syst Pharmacol. 2019 Aug 7;8(9):685-695), an initial loading dose of 400 mg followed by a maintenance dose of 200 mg once daily (QD) was selected as the itraconazole dosing regimen in this study.
Based on the predicted proportion of plasma exposure of metabolites from previous mass balance studies and combined with the previously established safety profile of Rocbrutinib, potent CYP3A inhibition is expected to potentially significantly increase the plasma concentration of Rocbrutinib when co-administered. Therefore, the clinically confirmed minimum effective dose of Rocbrutinib (100 mg) was chosen for co-administration Receives: Drug: Rocbrutinib tablets; Drug: Itraconazole capsules |
| Inducer Group | Experimental | The Inducer Group was designed to investigate the drug-drug interaction between Rocbrutinib and rifampicin (a potent CYP3A inducer and P-gp inhibitor). Rifampicin is a recommended potent index CYP3A inducer for clinical studies in the ICH-M12 Guideline on Drug Interactions. The maximum dose and shortest dosing interval in its clinically recommended regimen is 600 mg once daily (QD), so 600 mg QD was selected as the rifampicin dosing regimen in this study.
Potent CYP3A inducers are expected to either decrease the plasma concentration of Rocbrutinib or have no significant effect on it. Therefore, the clinically recommended higher dose of Rocbrutinib (200 mg) was chosen for co-administration with rifampicin in the Inducer Group.
In Cycle 2, Rocbrutinib administration was initiated on Day 10 (the 7th day after the start of continuous rifampicin dosing) and continued until the day before the last blood collection for Rocbrutinib (Day 12), which was sufficient to cover the in vivo drug meta Receives: Drug: Rocbrutinib tablets; Drug: Rifampicin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the curve
Measured: Until 72 hours or 96 hours after Rocbrutinib
Cmax
Plasma peak concentration of Rocbrutinib
Measured: Until 72 hours or 96 hours after Rocbrutinib
t1/2
Terminal phase half-life of Rocbrutinib
Measured: Until 72 hours or 96 hours after Rocbrutinib
Secondary outcomes (2)
Plasma coprophyrin I (CP-I) concentration
Plasma coprophyrin I (CP-I) concentration
Measured: Baseline and 24 hours after Rocbrutinib
Adverse events
Adverse events were evaluated by investigators based on clinical examination findings and observations in accordance with the CTCAE Version 5.0 criteria.
Measured: Up to 20 days after Rocbrutinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start5 Mar 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PharmacologyStudies of the same condition, open and under way.
- More trials run by Guangzhou Lupeng Pharmaceutical Company 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374224
- Sponsor's protocol ID
- LP-168-CN107
- Status last verified
- Mar 2026
- First submitted
- 16 Jan 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Since this is a clinical pharmacology study enrolling healthy subjects, it is planned to report the study results through peer-reviewed publications, and individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Two-part, Fixed-sequence Drug Interaction Study to Evaluate the Effects of Concomitant Use of the CYP3A4 Inhibitor Itraconazole or the CYP3A4 Inducer Rifampin on the Pharmacokinetics of Rocbrutinib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07374224
- Acronym / sponsor ID
- LP-168-CN107
- Conditions
- Clinical Pharmacology
- Keywords
- drug interaction, Rocbrutinib, LP-168, CYP3A4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 28 Jan 2026 (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 I, open-label, two-part, fixed-sequence drug interaction study conducted to evaluate the effects of concomitant use of the potent CYP3A4 inhibitor itraconazole or the CYP3A4 inducer rifampin on the pharmacokinetics of Rocbrutinib in healthy subjects.
Detailed description
This study evaluated the changes in the pharmacokinetic profiles of Rocbrutinib under maximal CYP3A inhibition and induction conditions by investigating the co-administration of Rocbrutinib with potent CYP3A inhibitors or inducers at steady state, compared with Rocbrutinib administered alone.
To assess the potential clinical inhibition of OATP1B by Rocbrutinib, blank plasma samples were collected prior to Rocbrutinib administration and 24-hour plasma samples were collected post-administration. The concentration of coproporphyrin I (CP-I) in these samples was detected and analyzed.
Furthermore, the effect of P-gp inhibitors on the drug absorption of Rocbrutinib (when acting as a substrate) was evaluated by investigating two scenarios: co-administration of a single dose of Rocbrutinib with a single dose of the P-gp inhibitor rifampicin, and co-administration of a single dose of Rocbrutinib with the P-gp inhibitor itraconazole at steady state.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhibitor Group | Experimental | Drug: Rocbrutinib tablets, Drug: Itraconazole capsulesThe Inhibitor Group was designed to investigate the drug-drug interaction between Rocbrutinib and itraconazole (a potent CYP3A inhibitor and P-gp inhibitor). Itraconazole is a recommended potent index CYP3A inhibitor for clinical studies in the ICH-M12 Guideline on Drug Interactions. In accordance with the recommendations in an industry white paper (CPT Pharmacometrics Syst Pharmacol. 2019 Aug 7;8(9):685-695), an initial loading dose of 400 mg followed by a maintenance dose of 200 mg once daily (QD) was selected as the itraconazole dosing regimen in this study. Based on the predicted proportion of plasma exposure of metabolites from previous mass balance studies and combined with the previously established safety profile of Rocbrutinib, potent CYP3A inhibition is expected to potentially significantly increase the plasma concentration of Rocbrutinib when co-administered. Therefore, the clinically confirmed minimum effective dose of Rocbrutinib (100 mg) was chosen for co-administration |
| Inducer Group | Experimental | Drug: Rocbrutinib tablets, Drug: Rifampicin capsulesThe Inducer Group was designed to investigate the drug-drug interaction between Rocbrutinib and rifampicin (a potent CYP3A inducer and P-gp inhibitor). Rifampicin is a recommended potent index CYP3A inducer for clinical studies in the ICH-M12 Guideline on Drug Interactions. The maximum dose and shortest dosing interval in its clinically recommended regimen is 600 mg once daily (QD), so 600 mg QD was selected as the rifampicin dosing regimen in this study. Potent CYP3A inducers are expected to either decrease the plasma concentration of Rocbrutinib or have no significant effect on it. Therefore, the clinically recommended higher dose of Rocbrutinib (200 mg) was chosen for co-administration with rifampicin in the Inducer Group. In Cycle 2, Rocbrutinib administration was initiated on Day 10 (the 7th day after the start of continuous rifampicin dosing) and continued until the day before the last blood collection for Rocbrutinib (Day 12), which was sufficient to cover the in vivo drug meta |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects had no history of serious digestive system (such as inflammatory bowel disease, chronic diarrhea, Crohn's disease, autonomic dysfunction affecting gastric emptying), nervous system, cardiovascular system, genitourinary system, respiratory system, metabolic and endocrine system, musculoskeletal system, hematologic system diseases, or tumors
- Subjects must agree to complete abstinence or use effective physical contraception (including sterilization, intrauterine device or barrier contraception) from the time of signing the informed consent form until 90 days after the last dose of medication, and have no plans to donate sperm or eggs during this period; if female subjects are using hormonal contraceptives, they must stop using them >14 days before the first dose and use at least one of the above contraceptive methods.
- Must be between 18 and 45 years old (inclusive) and be male or female when signing the informed consent form.
- Males weighing ≥50.0 kg or females weighing ≥45.0 kg, with a Body Mass Index (BMI) between 18.0 and 28.0 kg/m² (inclusive). BMI = weight (kg) / height² (m²).
- Able to understand and comply with the requirements of the research plan.
Key exclusion criteria (18 listed)
- Abnormalities in screening tests, such as vital signs, physical examination, or laboratory tests are clinically significant and may increase the risk of participants participating in the study or affect the scientific validity of the study.
- Abnormal electrocardiogram or myocardial enzyme levels that are clinically significant as determined by a clinician include, but are not limited to: QTcF ≥ 450 ms (corrected using the Fridricia formula, QTcF = QT/RR1/3, RR = 60/HR), etc.
- The test results for at least one of the following are positive: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, and syphilis-specific antibody.
- Patients who have taken the investigational drug within 4 weeks prior to or are required to take any drugs known to alter liver enzyme activity during the study period.
- The patient must have used any systemic medications (including any vaccines, prescription drugs, over-the-counter drugs, and traditional Chinese medicines), special medical purpose foods, or health supplements within two weeks prior to taking the investigational drug.
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 |
|---|---|---|
| Rocbrutinib tabletsDosage form: tablets Specification: 100 mg Dosage and administration: 100mg or 200mg, single dose, taken on the designated day according to the treatment plan. Dosage schedule: Depending on the cohort, subjects will need to take Rocbrutinib 2 times (inhibitor cohort) or 3 times (inducer cohort) during the study period. | Drug | Inducer Group, Inhibitor Group |
| Itraconazole capsulesDosage form: Capsules Specifications: 0.1g Dosage and administration: Take 400 mg (4*100 mg capsules) on Day 5, followed by 200 mg (2 100 mg capsules) once daily (QD) from Day 6 to Day 12. Duration of medication: The medication was administered for a total of 8 days during the study period. | Drug | Inhibitor Group |
| Rifampicin capsulesDosage form: Capsules Specifications: 0.15g Dosage and administration: Day 4-Day 12, take 600 mg (4 150 mg capsules) once daily (QD). Duration of medication: The medication was administered for a total of 9 days during the study period. | Drug | Inducer Group |
Primary outcome
AUC
Time frame: Until 72 hours or 96 hours after Rocbrutinib
Area under the curve
Cmax
Time frame: Until 72 hours or 96 hours after Rocbrutinib
Plasma peak concentration of Rocbrutinib
t1/2
Time frame: Until 72 hours or 96 hours after Rocbrutinib
Terminal phase half-life of Rocbrutinib
2 secondary outcomes
Plasma coprophyrin I (CP-I) concentration
Time frame: Baseline and 24 hours after Rocbrutinib
Adverse events
Time frame: Up to 20 days after Rocbrutinib
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 9 Mar 2026.
- Individual participant dataSharing planned: No. Since this is a clinical pharmacology study enrolling healthy subjects, it is planned to report the study results through peer-reviewed publications, and individual participant data will not be shared.
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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.
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 Rocbrutinib tablets, Itraconazole capsules and Rifampicin capsules in people with Clinical Pharmacology, run by Guangzhou Lupeng Pharmaceutical Company 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 18 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. 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?
Contact Dongyang Prof. Liu, PhD (+8618610966092, liudongyang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: Until 72 hours or 96 hours after Rocbrutinib). 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 9 Mar 2026.