A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects

Study Overview
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Brief Summary
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This is a phase I study to evaluate drug-drug interactions (DDIs) of JAB-21822 as a perpetrator combined with midazolam , rosuvastatin, and digoxin and to evaluate DDIs of JAB-21822 as a victim combined with itraconazole， rifampicin， and omeprazole in healthy subjects.

Official Title
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A Single-center, Non-randomized, Open-lable, Self-controlled Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: JAB-21822
* Drug: Itraconazole
* Drug: Omeprazole
* Drug: Midazolam , Rosuvastatin calcium and digoxin
* Drug: Rifampicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ；Healthy subjects aged 18 to 50 years (including both ends) at the time of signing informed consent Male subjects weighed ≥50kg, female subjects weighed ≥45kg, body mass index (BMI) was between 19.0 and 26.0kg/m2, BMI= weight (kg)/height 2 (m2), including boundary values. Subjects voluntarily signed written informed consent and were able to communicate well with the investigator Exclusion Criteria: History of severe systemic diseases, history of liver and kidney insufficiency, history of mental illness, history of drug dependence; Patients with a history of interstitial pneumonia, pulmonary fibrosis or other interstitial lung diseases who were not eligible for admission by the investigators; Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, and have digestive diseases (such as peptic ulcer, pancreatitis, colitis, etc.) within 3 months before the first dose; The investigator believes that the subject has any other circumstances that make him or her unfit to participate in this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JAB-21822+Itraconazole<br> | Drug: JAB-21822<br>* JAB-21822 was administered orally<br>Drug: Itraconazole<br>* Itraconazole was administered orally<br>|
| Experimental: JAB-21822+ Rifampicin<br> | Drug: JAB-21822<br>* JAB-21822 was administered orally<br>Drug: Rifampicin<br>* Rifampicin was administered orally<br>|
| Experimental: JAB-21822+ Omeprazole<br> | Drug: JAB-21822<br>* JAB-21822 was administered orally<br>Drug: Omeprazole<br>* Omeprazole was administered orally<br>|
| Experimental: Dazolam , Rosuvastatin calcium and digoxin with JAB-21822<br> | Drug: JAB-21822<br>* JAB-21822 was administered orally<br>Drug: Midazolam , Rosuvastatin calcium and digoxin<br>* Midazolam , Rosuvastatin calcium and digoxin was administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed maximum concentrations (Cmax )of JAB-21822 |  | approximately 10 days | 
| Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822 |  | approximately 10 days | 
| Area under the concentration versus time curve from dose to infinity (AUC0-∞) of JAB-21822 |  | approximately 10 days | 
| Observed maximum concentrations (Cmax )of midazolam, rosuvastatin, and digoxin |  | approximately 10 days | 
| Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of midazolam, rosuvastatin, and digoxin |  | approximately 10 days | 
| Area under the concentration versus time curve from dose to infinity (AUC0-∞) of midazolam, rosuvastatin, and digoxin |  | approximately 10 days |