NCT02892370

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

1 month

First QC Date

September 2, 2016

Last Update Submit

September 7, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • The number of volunteers with adverse events as a measure of safety

    up to Day 21

Study Arms (2)

SHR0302 fasted to fed

EXPERIMENTAL

SHR0302 tablets (10 mg) administered on day 1 fasting, and day 7 with high fat, high calorie breakfast

Drug: SHR0302

SHR0302 fed to fasted

EXPERIMENTAL

SHR0302 tablets (10 mg) administered on day 1 with high fat, high calorie breakfast, and day 7 fasting

Drug: SHR0302

Interventions

SHR0302DRUG

SHR0302 tablets (10 mg)

SHR0302 fasted to fedSHR0302 fed to fasted

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male
  • BMI:19-24 kg/m2, weight \> 50 kg.
  • Age:18-45

You may not qualify if:

  • History of clinically significant laboratory results or disease.
  • History of alcohol or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Chen Yu, BS

    Shanghai Xuhui Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengyu Guan, MD

CONTACT

86-21-50118402guanchengyu@hrs.com.cn

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

September 2, 2016

First Posted

September 8, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

CN(1)