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Completed

NCT Number: NCT04423601

Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);

Exclusion criteria

  • 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.

Treatment and study plan

SHR6390 tablet

Drug

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

Itraconazole capsule

Drug

200 mg itraconazole was administered in the morning.

Primary outcomes

  1. Pharmacokinetics parameter: Cmax of SHR6390

    Time frame: through study completion, an average of 32 days

    Peak Plasma Concentration (Cmax) of SHR6390

  2. Pharmacokinetics parameter: AUC of SHR6390

    Time frame: through study completion, an average of 32 days

    Area under the plasma concentration versus time curve (AUC) of SHR6390

Secondary outcomes

  1. Pharmacokinetics parameter: Tmax of SHR6390

    Time frame: through study completion, an average of 32 days

    Time of maximum observed concentration (Tmax) of SHR6390

  2. Pharmacokinetics parameter: T1/2 of SHR6390

    Time frame: through study completion, an average of 32 days

    Half time (T1/2) of SHR6390

  3. Pharmacokinetics parameter: CL/F of SHR6390

    Time frame: through study completion, an average of 32 days

    Total body clearance for extravascular administration (CL/F) of SHR6390

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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