Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects

Study Overview
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Brief Summary
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Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.

Detailed Description
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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.

Official Title
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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.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Hetrombopag


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Sequential Assignment
Interventional Model Description: rosuvastatin alone and then in combination with hetrombopag
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>rosuvastatin alone and then in combination with hetrombopag | Drug: Rosuvastatin<br>* Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11.<br>Drug: Hetrombopag<br>* 7.5 mg hetrombopag was administered on Day 6 to Day 11.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) |  | 0-72 hours post dose | 
| Area Under the plasma concentration vs time curve (AUC0-72) |  | 0-72 hours post dose | 
| Area under the blood concentration vs time curve (AUC0-inf) |  | 0-infinity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other pharmacokinetics parameters of rosuvastatin | Tmax | 0-72 hours post dose | 
| The number of volunteers with adverse events as a measure of safety and tolerability |  | up to Day 20 |