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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02892370
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
2
Duration (Months)
7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2016
Anticipated Study Completion Date :
Oct 1, 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. The maximum plasma concentration (Cmax) of SHR0302 [up to 72 hrs postdose]

    up to 72 hrs postdose on day1 and day7

  2. The area under the plasma concentration-time curve (AUC) of SHR0302 [up to 72 hrs postdose]

    up to 72 hrs postdose on day1 and day7

  3. The accumulative excretion rate of SHR0302 and its metabolites in urine and feces [up to 96 hrs postdose]

    up to 96 hrs postdose on day1 and day7

Secondary Outcome Measures

  1. The number of volunteers with adverse events as a measure of safety [up to Day 21]

    required last visit via telephone during D11 to D21

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Xuhui Central Hospital Shanghai Shanghai China 200030

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Chen Yu, BS, Shanghai Xuhui Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02892370
Other Study ID Numbers:
  • SHR0302-103
First Posted:
Sep 8, 2016
Last Update Posted:
Sep 8, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid

Study Results

No Results Posted as of Sep 8, 2016