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

NCT ID: NCT03603132

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-14
• Study Completion Date: 2018-08-17

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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Hetrombopag Olamine A

health subjects received 7.5 mg Hetrombopag Olamine while fasting.

Group Type: ACTIVE_COMPARATOR

Hetrombopag Olamine

Intervention Type: DRUG

7.5mg in each cycle

Hetrombopag Olamine B

health subjects received a high-fat meal one hour after taking7.5 mg Hetrombopag Olamine

Group Type: ACTIVE_COMPARATOR

Hetrombopag Olamine

Intervention Type: DRUG

7.5mg in each cycle

Hetrombopag Olamine C

health subjects received a high-fat meal two hours after taking7.5 mg Hetrombopag Olamine

Group Type: ACTIVE_COMPARATOR

Hetrombopag Olamine

Intervention Type: DRUG

7.5mg in each cycle

Interventions

Hetrombopag Olamine

7.5mg in each cycle

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The third xiangya hospital Hospital,of central south university

Changsha, Hunan, China

Countries

China

Other Identifiers

HR-TPO-Ig

Identifier Type: -

Identifier Source: org_study_id