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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Immune Thrombocytopenia

Treatments: Drug: Hetrombopag Olamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03603132

HR-TPO-Ig

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Hetrombopag Olamine A

Active Comparator group

Description:

health subjects received 7.5 mg Hetrombopag Olamine while fasting.

Treatment:

Drug: Hetrombopag Olamine

Hetrombopag Olamine B

Active Comparator group

Description:

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

Treatment:

Drug: Hetrombopag Olamine

Hetrombopag Olamine C

Active Comparator group

Description:

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

Treatment:

Drug: Hetrombopag Olamine