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

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

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: SHR0302

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Xuhui Central Hospital
      • Contact: Chen Yu; Phone Number: 86-21-54030254

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR0302 fasted to fed; SHR0302 tablets (10 mg) administered on day 1 fasting, and day 7 with high fat, high calorie breakfast	Drug: SHR0302; SHR0302 tablets (10 mg)
Experimental: SHR0302 fed to fasted; SHR0302 tablets (10 mg) administered on day 1 with high fat, high calorie breakfast, and day 7 fasting	Drug: SHR0302; SHR0302 tablets (10 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum plasma concentration (Cmax) of SHR0302	up to 72 hrs postdose on day1 and day7	up to 72 hrs postdose
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Chen Yu, BS, Shanghai Xuhui Central Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: SHR0302-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided