Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: SHR6390 tablet; Drug: Itraconazole capsule

• Registration Number: NCT04423601
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-07
• Study First Submitted QC: 2020-06-07
• Study First Posted: 2020-06-09
• Study Start: 2020-06-10
• Primary Completion: 2020-07-29
• Study Completion: 2021-02-02
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Itraconazole capsule	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.
Treatment	SHR6390 tablet	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China