Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the effect of itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with itraconazole. The exploratory objective of the study is to explore the effect of SHR6390 related metabolic enzymes and transporter gene polymorphisms on the pharmacokinetics of SHR6390.

Official Title
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A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Chinese Adult Subjects.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: SHR6390 tablet
* Drug: Itraconazole capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions; Ability to complete the study as required by the protocol; Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent; Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19   26 kg /m2 (including 19 and 26); Exclusion Criteria: Allergic constitution; History of drug use, or drug abuse screening positive; Alcoholic or often drinkers; Left ventricular ejection fraction (LVEF) <50% by echocardiography; A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>subjects receiving a single oral dose of SHR6390 tablets, then itraconazole capsules 200 mg/day orally with a single oral dose of SHR6390 tablets co-administered. | Drug: SHR6390 tablet<br>* single oral dose of SHR6390 or co-administered with itraconazole.<br>Drug: Itraconazole capsule<br>* 200 mg itraconazole was administered in the morning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameter: Cmax of SHR6390 | Peak Plasma Concentration (Cmax) of SHR6390 | through study completion, an average of 32 days | 
| Pharmacokinetics parameter: AUC of SHR6390 | Area under the plasma concentration versus time curve (AUC) of SHR6390 | through study completion, an average of 32 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameter: Tmax of SHR6390 | Time of maximum observed concentration (Tmax) of SHR6390 | through study completion, an average of 32 days | 
| Pharmacokinetics parameter: T1/2 of SHR6390 | Half time (T1/2) of SHR6390 | through study completion, an average of 32 days | 
| Pharmacokinetics parameter: CL/F of SHR6390 | Total body clearance for extravascular administration (CL/F) of SHR6390 | through study completion, an average of 32 days |