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NCT Number: NCT03603132

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The third xiangya hospital Hospital,of central south university

Changsha, Hunan, 410013, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Hetrombopag Olamine

Drug

7.5mg in each cycle

Primary outcomes

  1. Adverse events

    Time frame: from baseline up to Day 26

Secondary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 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

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 27, 2018
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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