A Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics

Immune Thrombocytopenia Clinical Trial

Official title:

Effects of Different Dosing and Feeding Intervals on the Pharmacokinetic Parameters of Herombopag Olamine Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603132
• Other study ID #: HR-TPO-Ig
• Status: Completed
• Phase: Phase 1
• Start date: July 14, 2018
• Est. completion date: August 17, 2018

Study information

• Verified date: May 2019
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 17, 2018
• Est. primary completion date: August 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years old

2. The subject's body weight was = 50.0 kg, BMI was between 19 and 26 kg/m2

3. Signed informed consent.

Exclusion Criteria:

1. 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

2. Having deep vein thrombosis or other thrombotic diseases.

3. Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur.

4. Extended QT interval during the screening period (calculated in Bazett's method, males >450 msec)

5. Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive.

6. Those who have a history of allergies to drugs , food or test drugs or similar drugs;

7. Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study

8. Those who took any drug within 14 days before the test (including Chinese herbal medicine)

9. Any drug that inhibits or induces liver drug metabolism within 30 days before the test

10. Subjects have participated in other clinical trial within the 3 months prior to study entry.

11. One or more non-pharmacological contraceptive measures cannot be used during the trial, or it is planned to have birth within six months.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Hetrombopag Olamine
7.5mg in each cycle

Locations

Country	Name	City	State
China	The third xiangya hospital Hospital,of central south university	Changsha	Hunan

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	Adverse events		from baseline up to Day 26
Secondary	Peak Plasma Concentration (Cmax)		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
Secondary	Area under the plasma concentration versus time curve (AUC)		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