Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04423601
• Other study ID #: SHR6390-I-106
• Status: Completed
• Phase: Phase 1
• Start date: June 10, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: October 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2, 2021
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• SHR6390 tablet
single oral dose of SHR6390 or co-administered with itraconazole.
• Itraconazole capsule
200 mg itraconazole was administered in the morning.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameter: Cmax of SHR6390	Peak Plasma Concentration (Cmax) of SHR6390	through study completion, an average of 32 days
Primary	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	Pharmacokinetics parameter: Tmax of SHR6390	Time of maximum observed concentration (Tmax) of SHR6390	through study completion, an average of 32 days
Secondary	Pharmacokinetics parameter: T1/2 of SHR6390	Half time (T1/2) of SHR6390	through study completion, an average of 32 days
Secondary	Pharmacokinetics parameter: CL/F of SHR6390	Total body clearance for extravascular administration (CL/F) of SHR6390	through study completion, an average of 32 days