Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects

February 2, 2015 updated by: Jiangsu HengRui Medicine Co., Ltd.

An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR3824 and Mass Balance Study in Healthy Volunteers

This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

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.
  • BMI 18-25 kg/m2.

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: SHR3824 10mg fasted to fed
SHR3824 tablet, fasting conditions day 1, visit 2, 7 days wash-out, SHR3824 tablet, high fat, high calorie breakfast day 1, visit 3.
Drug: SHR3824
SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.
Experimental: SHR3824 10mg fed to fasted
SHR3824, high fat, high calorie breakfast day 1, visit 2, 7 days wash-out, SHR3824, fasting conditions day 1, visit 3.
Drug: SHR3824
SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The maximum plasma concentration (Cmax) of SHR3824
Time Frame: Day 1-4 on visit 2 and visit 3
Cmax (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state
Day 1-4 on visit 2 and visit 3
The area under the plasma concentration-time curve (AUC) of SHR3824
Time Frame: Day 1-4 on visit 2 and visit 3
AUC (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state
Day 1-4 on visit 2 and visit 3
The accumulative excretion rate of SHR3824 and its metabolites in urine and feces
Time Frame: Day 1-4 on visit 2 and visit 3
Accumulative excretion rate will be compared under fating state and fasted state
Day 1-4 on visit 2 and visit 3

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of volunteers with adverse events as a measure of safety and tolerability.
Time Frame: Up to Day 12
Up to Day 12

Collaborators and Investigators

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

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

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

May 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 3, 2015

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHR3824-104

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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