Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05088343
Recruitment Status : Completed
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Rosuvastatin Drug: Hetrombopag Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: rosuvastatin alone and then in combination with hetrombopag
Masking: None (Open Label)
Primary Purpose: Basic Science
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.
Actual Study Start Date : September 7, 2020
Actual Primary Completion Date : January 16, 2021
Actual Study Completion Date : January 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
rosuvastatin alone and then in combination with hetrombopag
Drug: Rosuvastatin
Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11.

Drug: Hetrombopag
7.5 mg hetrombopag was administered on Day 6 to Day 11.




Primary Outcome Measures :
  1. Peak plasma concentration (Cmax) [ Time Frame: 0-72 hours post dose ]
  2. Area Under the plasma concentration vs time curve (AUC0-72) [ Time Frame: 0-72 hours post dose ]
  3. Area under the blood concentration vs time curve (AUC0-inf) [ Time Frame: 0-infinity ]

Secondary Outcome Measures :
  1. Other pharmacokinetics parameters of rosuvastatin [ Time Frame: 0-72 hours post dose ]
    Tmax

  2. The number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: up to Day 20 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05088343


Locations
Layout table for location information
China, Shanghai
Xueying General Ding
Shanghai, Shanghai, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Xueying Ding Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Layout table for additonal information
Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT05088343    
Other Study ID Numbers: SHR8735-110
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors