Rheumatoid ArthritisPhase 1NCT02892370
Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects
A Phase 1 study testing SHR0302 in people with Rheumatoid Arthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SHR0302
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male
- BMI:19-24 kg/m2, weight > 50 kg.
- Age:18-45
Who cannot join
- History of clinically significant laboratory results or disease.
- History of alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200030
Chen Yu, 86-21-54030254
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SHR0302
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302Drug
SHR0302 tablets (10 mg)
| Study group | Role | What they receive |
|---|---|---|
| SHR0302 fasted to fed | Experimental | SHR0302 tablets (10 mg) administered on day 1 fasting, and day 7 with high fat, high calorie breakfast Receives: 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 Receives: Drug: SHR0302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax) of SHR0302
up to 72 hrs postdose on day1 and day7
Measured: 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
Measured: 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
Measured: up to 96 hrs postdose
Secondary outcomes (1)
The number of volunteers with adverse events as a measure of safety
required last visit via telephone during D11 to D21
Measured: up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen Yu, BS, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892370
- Sponsor's protocol ID
- SHR0302-103
- Status last verified
- Sep 2016
- First submitted
- 2 Sep 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02892370
- Acronym / sponsor ID
- SHR0302-103
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR0302 fasted to fed | Experimental | Drug: SHR0302SHR0302 tablets (10 mg) administered on day 1 fasting, and day 7 with high fat, high calorie breakfast |
| SHR0302 fed to fasted | Experimental | Drug: SHR0302SHR0302 tablets (10 mg) administered on day 1 with high fat, high calorie breakfast, and day 7 fasting |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male
- BMI:19-24 kg/m2, weight > 50 kg.
- Age:18-45
Key exclusion criteria (2 listed)
- History of clinically significant laboratory results or disease.
- History of alcohol or drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR0302SHR0302 tablets (10 mg) | Drug | SHR0302 fasted to fed, SHR0302 fed to fasted |
Primary outcome
The maximum plasma concentration (Cmax) of SHR0302
Time frame: up to 72 hrs postdose
up to 72 hrs postdose on day1 and day7
The area under the plasma concentration-time curve (AUC) of SHR0302
Time frame: up to 72 hrs postdose
up to 72 hrs postdose on day1 and day7
The accumulative excretion rate of SHR0302 and its metabolites in urine and feces
Time frame: up to 96 hrs postdose
up to 96 hrs postdose on day1 and day7
1 secondary outcome
The number of volunteers with adverse events as a measure of safety
Time frame: up to Day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Yu, BS principal investigator
Xuhui Central Hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR0302 in people with Rheumatoid Arthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengyu Guan, MD (86-21-50118402, guanchengyu@hrs.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum plasma concentration (Cmax) of SHR0302 (time frame: up to 72 hrs postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.