Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects
An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR3824 and Mass Balance Study in Healthy Volunteers
1 other identifier
interventional
12
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 type-2-diabetes
Started May 2014
Shorter than P25 for phase_1 type-2-diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 20, 2015
CompletedFirst Posted
Study publicly available on registry
February 3, 2015
CompletedFebruary 3, 2015
January 1, 2015
2 months
January 20, 2015
February 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The maximum plasma concentration (Cmax) of SHR3824
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
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
Accumulative excretion rate will be compared under fating state and fasted state
Day 1-4 on visit 2 and visit 3
Secondary Outcomes (1)
The number of volunteers with adverse events as a measure of safety and tolerability.
Up to Day 12
Study Arms (2)
SHR3824 10mg fasted to fed
EXPERIMENTALSHR3824 tablet, fasting conditions day 1, visit 2, 7 days wash-out, SHR3824 tablet, high fat, high calorie breakfast day 1, visit 3.
SHR3824 10mg fed to fasted
EXPERIMENTALSHR3824, high fat, high calorie breakfast day 1, visit 2, 7 days wash-out, SHR3824, fasting conditions day 1, visit 3.
Interventions
SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.
Eligibility Criteria
You may qualify if:
- Healthy.
- BMI 18-25 kg/m2.
You may not qualify if:
- History of clinically significant illness.
- History of alcohol or drug abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2015
First Posted
February 3, 2015
Study Start
May 1, 2014
Primary Completion
July 1, 2014
Study Completion
September 1, 2014
Last Updated
February 3, 2015
Record last verified: 2015-01