Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects

April 3, 2015 updated by: Jiangsu HengRui Medicine Co., Ltd.
This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • West Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy.
  • Weight≥50 kg，19≤BMI≤28 kg/m2.
  • Platelet count is within normal range

Exclusion Criteria:

  • History of clinically significant illness.
  • History of alcohol or drug abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hetrombopag 7.5mg fasted to fed
Hetrombopag tablet, fasting conditions on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet with high fat, high calorie breakfast on day 11.
Drug: Hetrombopag Olamine
Experimental: hetrombopag 7.5mg fed to fasted
Hetrombopag tablet with high fat, high calorie breakfast on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet, under fasting condition on day 11.
Drug: Hetrombopag Olamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The maximum plasma concentration (Cmax) of hetrombopag
Time Frame: 0h-120h
Cmax (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
0h-120h
The area under the plasma concentration-time curve (AUC) of hetrombopag
Time Frame: 0h-120h
AUC (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
0h-120h
The accumulative excretion rate of hetrombopag and its metabolites in urine and feces
Time Frame: 0h-120h
0h-120h

Secondary Outcome Measures

Outcome Measure
Time Frame
The change of platelet count
Time Frame: On day 2, 4, 6, 8,12, 14 and 16
On day 2, 4, 6, 8,12, 14 and 16
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame: up to Day 16
up to Day 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 3, 2015

First Posted (Estimate)

April 6, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 3, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TPOP1c

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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