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

NCT03603132 | Completed Phase 1

• 1 other identifier: HR-TPO-Ig
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adverse events

  from baseline up to Day 26

Secondary Outcomes (2)

• 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

• 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

Study Arms (3)

Hetrombopag Olamine A

ACTIVE COMPARATOR

health subjects received 7.5 mg Hetrombopag Olamine while fasting.

Drug: Hetrombopag Olamine

Hetrombopag Olamine B

ACTIVE COMPARATOR

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

Drug: Hetrombopag Olamine

Hetrombopag Olamine C

ACTIVE COMPARATOR

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

Drug: Hetrombopag Olamine

Interventions

Hetrombopag Olamine DRUG

7.5mg in each cycle

Hetrombopag Olamine A; Hetrombopag Olamine B; Hetrombopag Olamine C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The third xiangya hospital Hospital,of central south university

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 27, 2018
• Study Start: July 14, 2018
• Primary Completion: August 17, 2018
• Study Completion: August 17, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)