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Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects

NCT ID: NCT05088343

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-07

Study Completion Date

2021-01-16

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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

rosuvastatin alone and then in combination with hetrombopag
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment

rosuvastatin alone and then in combination with hetrombopag

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11.

Hetrombopag

Intervention Type DRUG

7.5 mg hetrombopag was administered on Day 6 to Day 11.

Interventions

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Rosuvastatin

Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11.

Intervention Type DRUG

Hetrombopag

7.5 mg hetrombopag was administered on Day 6 to Day 11.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xueying Ding

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Xueying General Ding

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SHR8735-110

Identifier Type: -

Identifier Source: org_study_id