Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

NCT04423601 | Completed Phase 1

• 1 other identifier: SHR6390-I-106
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pharmacokinetics parameter: Tmax of SHR6390

  through study completion, an average of 32 days

• Pharmacokinetics parameter: T1/2 of SHR6390

  through study completion, an average of 32 days

• Pharmacokinetics parameter: CL/F of SHR6390

  through study completion, an average of 32 days

Study Arms (1)

Treatment

EXPERIMENTAL

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; Drug: Itraconazole capsule

Interventions

SHR6390 tablet DRUG

single oral dose of SHR6390 or co-administered with itraconazole.

Treatment

Itraconazole capsule DRUG

200 mg itraconazole was administered in the morning.

Treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 9, 2020
• Study Start: June 10, 2020
• Primary Completion: July 29, 2020
• Study Completion: February 2, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

CN (1)