Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects

Healthy Subjects Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05088343
• Other study ID #: SHR8735-110
• Status: Completed
• Phase: Phase 1
• Start date: September 7, 2020
• Est. completion date: January 16, 2021

Study information

• Verified date: February 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 16, 2021
• Est. primary completion date: January 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Rosuvastatin
Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11.
• Hetrombopag
7.5 mg hetrombopag was administered on Day 6 to Day 11.

Locations

Country	Name	City	State
China	Xueying General Ding	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak plasma concentration (Cmax)		0-72 hours post dose
Primary	Area Under the plasma concentration vs time curve (AUC0-72)		0-72 hours post dose
Primary	Area under the blood concentration vs time curve (AUC0-inf)		0-infinity
Secondary	Other pharmacokinetics parameters of rosuvastatin	Tmax	0-72 hours post dose
Secondary	The number of volunteers with adverse events as a measure of safety and tolerability		up to Day 20