Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects

Rheumatoid Arthritis Clinical Trial

Official title:

An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02892370
• Other study ID #: SHR0302-103
• Status: Recruiting
• Phase: Phase 1
• First received: September 2, 2016
• Last updated: September 7, 2016
• Start date: August 2016
• Est. completion date: October 2016

Study information

• Verified date: September 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Chengyu Guan, MD
• Phone: 86-21-50118402
• Email: guanchengyu[@]hrs.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• SHR0302
SHR0302 tablets (10 mg)

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum plasma concentration (Cmax) of SHR0302	up to 72 hrs postdose on day1 and day7	up to 72 hrs postdose	No
Primary	The area under the plasma concentration-time curve (AUC) of SHR0302	up to 72 hrs postdose on day1 and day7	up to 72 hrs postdose	No
Primary	The accumulative excretion rate of SHR0302 and its metabolites in urine and feces	up to 96 hrs postdose on day1 and day7	up to 96 hrs postdose	No
Secondary	The number of volunteers with adverse events as a measure of safety	required last visit via telephone during D11 to D21	up to Day 21	Yes