Back to resultsEffect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR0302
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Healthy male
- BMI:19-24 kg/m2, weight > 50 kg.
- Age:18-45
Exclusion Criteria:
- History of clinically significant laboratory results or disease.
- History of alcohol or drug abuse.
Sites / Locations
- Shanghai Xuhui Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SHR0302 fasted to fed
SHR0302 fed to fasted
Arm Description
SHR0302 tablets (10 mg) administered on day 1 fasting, and day 7 with high fat, high calorie breakfast
SHR0302 tablets (10 mg) administered on day 1 with high fat, high calorie breakfast, and day 7 fasting
Outcomes
Primary Outcome Measures
The maximum plasma concentration (Cmax) of SHR0302
up to 72 hrs postdose on day1 and day7
The area under the plasma concentration-time curve (AUC) of SHR0302
up to 72 hrs postdose on day1 and day7
The accumulative excretion rate of SHR0302 and its metabolites in urine and feces
up to 96 hrs postdose on day1 and day7
Secondary Outcome Measures
The number of volunteers with adverse events as a measure of safety
required last visit via telephone during D11 to D21
Full Information
NCT ID
NCT02892370
First Posted
September 2, 2016
Last Updated
September 7, 2016
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02892370
Brief Title
Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects
Official Title
An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR0302 fasted to fed
Arm Type
Experimental
Arm Description
SHR0302 tablets (10 mg) administered on day 1 fasting, and day 7 with high fat, high calorie breakfast
Arm Title
SHR0302 fed to fasted
Arm Type
Experimental
Arm Description
SHR0302 tablets (10 mg) administered on day 1 with high fat, high calorie breakfast, and day 7 fasting
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
SHR0302 tablets (10 mg)
Primary Outcome Measure Information:
Title
The maximum plasma concentration (Cmax) of SHR0302
Description
up to 72 hrs postdose on day1 and day7
Time Frame
up to 72 hrs postdose
Title
The area under the plasma concentration-time curve (AUC) of SHR0302
Description
up to 72 hrs postdose on day1 and day7
Time Frame
up to 72 hrs postdose
Title
The accumulative excretion rate of SHR0302 and its metabolites in urine and feces
Description
up to 96 hrs postdose on day1 and day7
Time Frame
up to 96 hrs postdose
Secondary Outcome Measure Information:
Title
The number of volunteers with adverse events as a measure of safety
Description
required last visit via telephone during D11 to D21
Time Frame
up to Day 21
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male
BMI:19-24 kg/m2, weight > 50 kg.
Age:18-45
Exclusion Criteria:
History of clinically significant laboratory results or disease.
History of alcohol or drug abuse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengyu Guan, MD
Phone
86-21-50118402
Email
guanchengyu@hrs.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Yu, BS
Organizational Affiliation
Shanghai Xuhui Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Xuhui Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Yu
Phone
86-21-54030254
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects
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