Back to resultsA Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics
Primary Purpose
Immune Thrombocytopenia
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Hetrombopag Olamine
Sponsored by
About this trial
This is an interventional other trial for Immune Thrombocytopenia
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2
- Signed informed consent.
Exclusion Criteria:
- Any clinically serious disease that has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that can interfere with the test results
- Having deep vein thrombosis or other thrombotic diseases.
- Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur.
- Extended QT interval during the screening period (calculated in Bazett's method, males >450 msec)
- Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive.
- Those who have a history of allergies to drugs , food or test drugs or similar drugs;
- Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study
- Those who took any drug within 14 days before the test (including Chinese herbal medicine)
- Any drug that inhibits or induces liver drug metabolism within 30 days before the test
- Subjects have participated in other clinical trial within the 3 months prior to study entry.
- One or more non-pharmacological contraceptive measures cannot be used during the trial, or it is planned to have birth within six months.
Sites / Locations
- The third xiangya hospital Hospital,of central south university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Hetrombopag Olamine A
Hetrombopag Olamine B
Hetrombopag Olamine C
Arm Description
health subjects received 7.5 mg Hetrombopag Olamine while fasting.
health subjects received a high-fat meal one hour after taking7.5 mg Hetrombopag Olamine
health subjects received a high-fat meal two hours after taking7.5 mg Hetrombopag Olamine
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)
Full Information
NCT ID
NCT03603132
First Posted
June 18, 2018
Last Updated
May 5, 2019
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03603132
Brief Title
A Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics
Official Title
Effects of Different Dosing and Feeding Intervals on the Pharmacokinetic Parameters of Herombopag Olamine Tablets
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 14, 2018 (Actual)
Primary Completion Date
August 17, 2018 (Actual)
Study Completion Date
August 17, 2018 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study use a single-center, randomized, open, three-cycle, self-control trial design. It is planning to enroll 15 healthy adult male subjects. Fifteen subjects will randomize into 3 test groups which corresponding to 3 different dosing sequences. Subjects will be giving a single oral dose in per cycle, and there will have three types of breakfast administration after each treatment. Washing period is 10 days during the cycle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hetrombopag Olamine A
Arm Type
Active Comparator
Arm Description
health subjects received 7.5 mg Hetrombopag Olamine while fasting.
Arm Title
Hetrombopag Olamine B
Arm Type
Active Comparator
Arm Description
health subjects received a high-fat meal one hour after taking7.5 mg Hetrombopag Olamine
Arm Title
Hetrombopag Olamine C
Arm Type
Active Comparator
Arm Description
health subjects received a high-fat meal two hours after taking7.5 mg Hetrombopag Olamine
Intervention Type
Drug
Intervention Name(s)
Hetrombopag Olamine
Intervention Description
7.5mg in each cycle
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
from baseline up to Day 26
Secondary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Time Frame
pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old
The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2
Signed informed consent.
Exclusion Criteria:
Any clinically serious disease that has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that can interfere with the test results
Having deep vein thrombosis or other thrombotic diseases.
Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur.
Extended QT interval during the screening period (calculated in Bazett's method, males >450 msec)
Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive.
Those who have a history of allergies to drugs , food or test drugs or similar drugs;
Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study
Those who took any drug within 14 days before the test (including Chinese herbal medicine)
Any drug that inhibits or induces liver drug metabolism within 30 days before the test
Subjects have participated in other clinical trial within the 3 months prior to study entry.
One or more non-pharmacological contraceptive measures cannot be used during the trial, or it is planned to have birth within six months.
Facility Information:
Facility Name
The third xiangya hospital Hospital,of central south university
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics
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