Healthy Adult SubjectsPhase 1NCT04335266
A Food Effect Study of SHR2554 on Healthy Chinese Male Adult Subjects
A Phase 1 study testing SHR2554 in people with Healthy Adult Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese male adult subjects after oral administration of SHR2554 tablets. The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- SHR2554
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2019to 30 Mar 2020
- 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 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 40~60 at the date of signing the informed consent;
- Male body weight ≥ 50kg , body mass index (BMI) within the range of 19 ~ 28kg /m2 (including 19 and 28) (BMI= weight (kg)/height 2 (m2));
- During screening period physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation, abdominal ultrasound, chest X-ray and other examination results must be within the normal range consistent with age and gender, or in accordance with the protocol, or judged to be "no clinical significance (NCS)" if beyond the normal range;
- Agree to abstain from sex or use effective non-drug contraceptives from screening to at least 3 months after the last study drug administration (female subjects are also required to abstain or use effective non-drug contraceptives two weeks prior to study entry);
- The subject can communicate well with the researcher, understand and comply with the requirements of the study, understand and sign the informed consent.
Who cannot join
- Allergic constitution or known allergy to the research drug/similar drugs;
- Frequent use of sedatives, sleeping pills or other addictive drugs; History of drug abuse within 6 months prior to first administration or drug abuse screening positive; Alcoholic or often drinkers within 6 months prior to screening, the average drinking amount is more than 14 units a week (1 unit= 285 ml beer or 25 ml alcohol content of 40% spirits or 100 ml wine), a heavy smoker or quitting time less than 3 months, alcohol breath test positive and nicotine test positive, and can't quit smoking and alcohol during the study;
- A history of cardiovascular diseases such as myocarditis, coronary heart disease, pathological arrhythmia and stroke;
- Pulmonary diseases, including invasive lung disease, pneumonia, and dyspnoea;
- Chronic kidney disease, renal insufficiency, renal anaemia;
- A history of dysphagia or any gastrointestinal disease affecting drug absorption;
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- Any uncontrolled peptic ulcer, colitis, pancreatitis, etc;
- Any operation within the previous 3 months that may affect the absorption, distribution, metabolism and excretion of drugs;
- Previous medical history of cardiovascular, liver, kidney, lung, digestive tract, nervous system diseases, etc., which may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may pose a hazard to the subjects participating in the study. The following medical history or conditions should be considered: inflammatory gastroenteritis, gastroesophageal reflux, gastrointestinal or rectal bleeding; History of pancreatic injury or pancreatitis; Greater surgical history such as gastrectomy, gastroenterostomy, or enterectomy; History of acute and chronic renal insufficiency, history of renal transplantation;
- Taking any hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole and rifampicin) in the months prior to screening;
- hose who have participated in other clinical trials and taken the research drugs within 3 months before the first drug administration;
- Any drug that altered the activity of liver enzymes was given 28 days prior to administration or during the study;
- Use any prescription drug or herbal tonic within one week before the first dose;
- Use any over-the-counter (OTC) or food supplement (including vitamins, calcium tablets, etc.) within one weeks before the first dose;
- Clinical laboratory examination is abnormal and to be CS;
- Hepatitis B surface antigen positive, hepatitis C2 antibody positive, syphilis antibody positive, HIV antibody positive;
- Subjects refused to stop using any beverage or food containing methyl xanthine, such as coffee, tea, cola, chocolate, etc. from 48 hours before the first administration until the end of the study;
- Blood donation within 3 months before the screening or blood loss great than 400 mL;
- Difficulty in venous blood collection or inability to tolerate venepuncture;
- Other factors (including but not limited to inability to understand the requirements of the study, poor compliance, physical weakness, etc.) that are not suitable for participating in the study, as judged by the researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open, Single-center, Two-cycle, Double-sequence Crossover Study to Investigate the Effects of a High-fat Diet on the Pharmacokinetics of Healthy Chinese Male Adult Subjects After Oral Administration of SHR2554 Tablets
The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese male adult subjects after oral administration of SHR2554 tablets.
The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects.
- Conditions
- Healthy Adult Subjects
- Being tested
- SHR2554
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2554Drug
SHR2554
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR2554 fasted in P1, high-fat diet in P2 SHR2554 administration in fasted condition in period 1, SHR2554 administration after high-fat diet in period 2 Receives: Drug: SHR2554 |
| Treatment group B | Experimental | Drug: SHR2554 high-fat diet in P1, fasted in P2 SHR2554 administration after high-fat diet in period 1, SHR2554 administration in fasted condition in period 2 Receives: Drug: SHR2554 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameter: Cmax of SHR2554
Peak Plasma Concentration (Cmax) of SHR2554
Measured: Day 1 and Day 8 of the single dose
Pharmacokinetics parameter: AUC of SHR2554
Area under the plasma concentration versus time curve (AUC) of SHR2554
Measured: Day 1 and Day 8 of the single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start6 Aug 2019
- Primary completion9 Sep 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335266
- Sponsor's protocol ID
- SHR2554-I-103
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 6 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Single-center, Two-cycle, Double-sequence Crossover Study to Investigate the Effects of a High-fat Diet on the Pharmacokinetics of Healthy Chinese Male Adult Subjects After Oral Administration of SHR2554 Tablets
- ClinicalTrials.gov ID
- NCT04335266
- Acronym / sponsor ID
- SHR2554-I-103
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 6 Apr 2020 (actual)
- 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 primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese male adult subjects after oral administration of SHR2554 tablets.
The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR2554Drug: SHR2554 fasted in P1, high-fat diet in P2 SHR2554 administration in fasted condition in period 1, SHR2554 administration after high-fat diet in period 2 |
| Treatment group B | Experimental | Drug: SHR2554Drug: SHR2554 high-fat diet in P1, fasted in P2 SHR2554 administration after high-fat diet in period 1, SHR2554 administration in fasted condition in period 2 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects aged 40~60 at the date of signing the informed consent;
- Male body weight ≥ 50kg , body mass index (BMI) within the range of 19 ~ 28kg /m2 (including 19 and 28) (BMI= weight (kg)/height 2 (m2));
- During screening period physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation, abdominal ultrasound, chest X-ray and other examination results must be within the normal range consistent with age and gender, or in accordance with the protocol, or judged to be "no clinical significance (NCS)" if beyond the normal range;
- Agree to abstain from sex or use effective non-drug contraceptives from screening to at least 3 months after the last study drug administration (female subjects are also required to abstain or use effective non-drug contraceptives two weeks prior to study entry);
- The subject can communicate well with the researcher, understand and comply with the requirements of the study, understand and sign the informed consent.
Key exclusion criteria (20 listed)
- Allergic constitution or known allergy to the research drug/similar drugs;
- Frequent use of sedatives, sleeping pills or other addictive drugs; History of drug abuse within 6 months prior to first administration or drug abuse screening positive; Alcoholic or often drinkers within 6 months prior to screening, the average drinking amount is more than 14 units a week (1 unit= 285 ml beer or 25 ml alcohol content of 40% spirits or 100 ml wine), a heavy smoker or quitting time less than 3 months, alcohol breath test positive and nicotine test positive, and can't quit smoking and alcohol during the study;
- A history of cardiovascular diseases such as myocarditis, coronary heart disease, pathological arrhythmia and stroke;
- Pulmonary diseases, including invasive lung disease, pneumonia, and dyspnoea;
- Chronic kidney disease, renal insufficiency, renal anaemia;
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 |
|---|---|---|
| SHR2554SHR2554 | Drug | Treatment group A, Treatment group B |
Primary outcome
Pharmacokinetics parameter: Cmax of SHR2554
Time frame: Day 1 and Day 8 of the single dose
Peak Plasma Concentration (Cmax) of SHR2554
Pharmacokinetics parameter: AUC of SHR2554
Time frame: Day 1 and Day 8 of the single dose
Area under the plasma concentration versus time curve (AUC) of SHR2554
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: No
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Healthy Subjects
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.
The record lists no contact. Use the official record to reach the sponsor.
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 SHR2554 in people with Healthy Adult Subjects, 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 5 inclusion and 20 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: finished, as of the sponsor's last update on 6 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics parameter: Cmax of SHR2554 (time frame: Day 1 and Day 8 of the single dose). The study lists 2 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 6 Apr 2020.