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A Trial of Hetrombopag in Healthy Subjects

Primary Purpose

Sever Aplastic Anaemia

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Hetrombopag Olamine Tablet;Ciclosporin Soft Capsule
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sever Aplastic Anaemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
  2. Male or female subjects aged 18-55 years (inclusive);
  3. Body mass index (BMI) between 18 and 26 kg/m2 (inclusive);
  4. Normal or abnormal but not clinically significant physical examination and laboratory test results; normal or abnormal but not clinically significant ECG;
  5. Have no plan for pregnancy and agree to take effective contraceptive measures from signing of informed consent form until 6 months after the last dose;
  6. Able to maintain a consistency of good communication with the investigators, and understand and comply with all the requirements of this study

Exclusion Criteria:

  1. Any previous or current serious clinical conditions of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, and hematological, immunological, psychiatric and metabolic abnormalities, or any disease that may interfere with the results of this study;
  2. History of deep venous thrombosis or other thrombotic disorders;
  3. QTc > 450 ms in males or QTc > 460 ms in females through 12-lead ECG examination with clinical significance per the investigator's judgment at screening;
  4. Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody (trust), or HIV antibody;
  5. Positive pregnancy test result;
  6. Allergic constitution, or allergy to any component of hetrombopag olamine tablets and ciclosporin capsules;
  7. Have received surgery within 4 weeks before the first study administration, or plan to undergo surgery during the course of the study;
  8. Have taken any drug that alters liver enzyme activity within 28 days before the first study administration or during the study;
  9. Have taken any prescription drug, over-the-counter drug, herbal medicine, or health supplements within 14 days before the first study administration, or within 5 half-lives of the drug at screening; plan to take non-study drugs or health supplements during the study;
  10. Consumption of grapefruit or grapefruit-containing products, foods or beverages containing caffeine, xanthine, or alcohol within 48 h before the first study administration; strenuous exercise, or other factors that affect drug absorption, distribution, metabolism, and excretion;
  11. Have participated in any drug clinical trial and have been treated with any investigational drug or medical device within 3 months before the first study administration (per the date of signing the informed consent form);
  12. Have blood donation (or blood loss) of ≥ 400 mL or have received blood transfusion within 3 months before screening;
  13. Unable or unwilling to comply with the lifestyle requirements in the protocol;
  14. Addicted to smoking (≥ 5 cigarettes per day within 1 month before screening);
  15. Average daily alcohol consumption of > 15 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) and > 25 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol liquor) within 1 month before screening;
  16. History of drug abuse, history of drug dependence, or drug abuse screening positive (drugs include morphine, methamphetamine, ketamine, ecstasy (dimethylene dioxyamphetamine), and cannabis (tetrahydrocannabinol)) (consultation and examination), or history of drug abuse within the past five years or have used narcotics within 3 months before the study;
  17. Potentially unable to complete the study for other reasons or judged by the investigator as not suitable for the study.
  18. Intolerant to venipuncture, or history of hemophobia or fear of needles;
  19. Have special dietary requirements and unable to accept a standardized diet;
  20. Acute disease from screening to first study administration.

Sites / Locations

  • West China Second University Hospital Ethics Committee

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

D1:hetrombopag single dose,D11-D15:cyclosporine,D16 combination use of hetrombopag and cyclosporine

Arm Description

Outcomes

Primary Outcome Measures

Peak hetrombopag plasma concentration (Cmax)
Area Under the plasma hetrombopag concentration vs time curve (AUC0-120)
Area under the plasma hetrombopag concentration vs time curve (AUC0-inf)

Secondary Outcome Measures

Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Half-life Associated With the Terminal Slope (t½)
The number of volunteers with adverse events as a measure of safety and tolerability

Full Information

First Posted
October 12, 2021
Last Updated
October 12, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05088174
Brief Title
A Trial of Hetrombopag in Healthy Subjects
Official Title
A Single-Center, Single-Arm, Open-Label, Self-Controlled, Drug-Drug Interaction Study of Hetrombopag Olamine and Ciclosporin in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
October 22, 2020 (Actual)
Study Completion Date
October 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a single-center, single-arm, open-label, self-controlled, phase I clinical study. A total of 26 male or female healthy subjects are intended to be enrolled to evaluate the PK drug-drug interaction between ciclosporin and hetrombopag.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sever Aplastic Anaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D1:hetrombopag single dose,D11-D15:cyclosporine,D16 combination use of hetrombopag and cyclosporine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hetrombopag Olamine Tablet;Ciclosporin Soft Capsule
Intervention Description
Drug: Hetrombopag Olamine Tablet Ciclosporin Soft Capsule
Primary Outcome Measure Information:
Title
Peak hetrombopag plasma concentration (Cmax)
Time Frame
0-120 hours post dose
Title
Area Under the plasma hetrombopag concentration vs time curve (AUC0-120)
Time Frame
0-120 hours post dose
Title
Area under the plasma hetrombopag concentration vs time curve (AUC0-inf)
Time Frame
0-infinity
Secondary Outcome Measure Information:
Title
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Time Frame
0-120 hours post dose
Title
Half-life Associated With the Terminal Slope (t½)
Time Frame
0-120 hours post dose
Title
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame
up to Day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol; Male or female subjects aged 18-55 years (inclusive); Body mass index (BMI) between 18 and 26 kg/m2 (inclusive); Normal or abnormal but not clinically significant physical examination and laboratory test results; normal or abnormal but not clinically significant ECG; Have no plan for pregnancy and agree to take effective contraceptive measures from signing of informed consent form until 6 months after the last dose; Able to maintain a consistency of good communication with the investigators, and understand and comply with all the requirements of this study Exclusion Criteria: Any previous or current serious clinical conditions of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, and hematological, immunological, psychiatric and metabolic abnormalities, or any disease that may interfere with the results of this study; History of deep venous thrombosis or other thrombotic disorders; QTc > 450 ms in males or QTc > 460 ms in females through 12-lead ECG examination with clinical significance per the investigator's judgment at screening; Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody (trust), or HIV antibody; Positive pregnancy test result; Allergic constitution, or allergy to any component of hetrombopag olamine tablets and ciclosporin capsules; Have received surgery within 4 weeks before the first study administration, or plan to undergo surgery during the course of the study; Have taken any drug that alters liver enzyme activity within 28 days before the first study administration or during the study; Have taken any prescription drug, over-the-counter drug, herbal medicine, or health supplements within 14 days before the first study administration, or within 5 half-lives of the drug at screening; plan to take non-study drugs or health supplements during the study; Consumption of grapefruit or grapefruit-containing products, foods or beverages containing caffeine, xanthine, or alcohol within 48 h before the first study administration; strenuous exercise, or other factors that affect drug absorption, distribution, metabolism, and excretion; Have participated in any drug clinical trial and have been treated with any investigational drug or medical device within 3 months before the first study administration (per the date of signing the informed consent form); Have blood donation (or blood loss) of ≥ 400 mL or have received blood transfusion within 3 months before screening; Unable or unwilling to comply with the lifestyle requirements in the protocol; Addicted to smoking (≥ 5 cigarettes per day within 1 month before screening); Average daily alcohol consumption of > 15 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) and > 25 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol liquor) within 1 month before screening; History of drug abuse, history of drug dependence, or drug abuse screening positive (drugs include morphine, methamphetamine, ketamine, ecstasy (dimethylene dioxyamphetamine), and cannabis (tetrahydrocannabinol)) (consultation and examination), or history of drug abuse within the past five years or have used narcotics within 3 months before the study; Potentially unable to complete the study for other reasons or judged by the investigator as not suitable for the study. Intolerant to venipuncture, or history of hemophobia or fear of needles; Have special dietary requirements and unable to accept a standardized diet; Acute disease from screening to first study administration.
Facility Information:
Facility Name
West China Second University Hospital Ethics Committee
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Trial of Hetrombopag in Healthy Subjects

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