Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

• Status: Completed
• Trial end date: 2021-02-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Itraconazole

Criteria

Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;

2. Ability to complete the study as required by the protocol;

3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;

4. 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:

1. Allergic constitution;

2. History of drug use, or drug abuse screening positive;

3. Alcoholic or often drinkers;

4. Left ventricular ejection fraction (LVEF) <50% by echocardiography;

5. 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.

6. 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.