Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment 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
single oral dose of SHR6390 or co-administered with itraconazole.
Drug: Itraconazole capsule
200 mg itraconazole was administered in the morning.
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics parameter: Cmax of SHR6390 [through study completion, an average of 32 days]
Peak Plasma Concentration (Cmax) of SHR6390
- Pharmacokinetics parameter: AUC of SHR6390 [through study completion, an average of 32 days]
Area under the plasma concentration versus time curve (AUC) of SHR6390
Secondary Outcome Measures
- Pharmacokinetics parameter: Tmax of SHR6390 [through study completion, an average of 32 days]
Time of maximum observed concentration (Tmax) of SHR6390
- Pharmacokinetics parameter: T1/2 of SHR6390 [through study completion, an average of 32 days]
Half time (T1/2) of SHR6390
- Pharmacokinetics parameter: CL/F of SHR6390 [through study completion, an average of 32 days]
Total body clearance for extravascular administration (CL/F) of SHR6390
Eligibility Criteria
Criteria
Inclusion Criteria:
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Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
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Ability to complete the study as required by the protocol;
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Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
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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:
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Allergic constitution;
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History of drug use, or drug abuse screening positive;
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Alcoholic or often drinkers;
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Left ventricular ejection fraction (LVEF) <50% by echocardiography;
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | 510120 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR6390-I-106