Clinical trial NCT05088343: Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
Official title: A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Chinese Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: rosuvastatin alone and then in combination with hetrombopag
Primary purpose: BASIC_SCIENCE

Brief summary: Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.

Detailed description: The primary objective of the study is to evaluate the effect of hetrombopag on pharmacokinetics of healthy Chinese adult subjects after oral administration of rosuvastatin calcium tablets. The secondary objective of the study is to evaluate the safety of rosuvastatin alone and when co-administered with hetrombopag.

Eligibility criteria: 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 55 (including 18 and 55) 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;
* History of deep vein thrombosis, or any other thromboembolic event;
* 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.

Primary outcomes:
measure: Peak plasma concentration (Cmax)
timeFrame: 0-72 hours post dose
measure: Area Under the plasma concentration vs time curve (AUC0-72)
timeFrame: 0-72 hours post dose
measure: Area under the blood concentration vs time curve (AUC0-inf)
timeFrame: 0-infinity
Secondary outcomes:
measure: Other pharmacokinetics parameters of rosuvastatin
timeFrame: 0-72 hours post dose
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to Day 20
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xueying General Ding
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Xueying Ding
role: PRINCIPAL_INVESTIGATOR
References: