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

Phase 1

Completed

• Conditions: Immune Thrombocytopenia
• Interventions: Drug: Hetrombopag Olamine

• Registration Number: NCT03603132
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-18
• Study Start: 2018-07-14
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-27
• Primary Completion: 2018-08-17
• Study Completion: 2018-08-17
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-05
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hetrombopag Olamine A	Hetrombopag Olamine	health subjects received 7.5 mg Hetrombopag Olamine while fasting.
Hetrombopag Olamine B	Hetrombopag Olamine	health subjects received a high-fat meal one hour after taking7.5 mg Hetrombopag Olamine
Hetrombopag Olamine C	Hetrombopag Olamine	health subjects received a high-fat meal two hours after taking7.5 mg Hetrombopag Olamine

Primary Outcome Measures

Name	Time	Method
Adverse events	from baseline up to Day 26

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

The third xiangya hospital Hospital,of central south university; 🇨🇳 Changsha, Hunan, China