Healthy Adult SubjectsPhase 1NCT04291846

A Food Effect Study of SHR1459 on Healthy Chinese Adult Subjects

A Phase 1 study testing SHR1459 fasted in P1, high-fat diet in P2 and SHR1459 high-fat diet in P1, fasted in P2 in people with Healthy Adult Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR1459 tablets. The secondary objective of the study is to evaluate the safety of single dose of SHR1459 orally in healthy subjects. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Adult Subjects
What is being tested?: SHR1459 fasted in P1, high-fat diet in P2 and SHR1459 high-fat diet in P1, fasted in P2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteChina
Study dates: 24 May 2020to 29 Jun 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male or female subjects aged 18 or above (including 18 years old) at the date of signing the informed consent;
Male body weight ≥ 50kg, female body weight ≥ 45kg, 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;
The 12-lead ECG should be normal, with male QTcF < 430ms and female QTcF < 450ms; QTc interval is corrected by Fridericia formula (QTcF = QT/(RR^0.33), RR is the standardized heart rate value, calculated by dividing heart rate by 60);
Negative pregnancy test for women of child-bearing age;
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 12 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= 360 ml beer or 45 ml alcohol content of 40% spirits or 150 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;
Use any prescription drug or herbal tonic within one month before the first dose; Use any over-the-counter (OTC) or food supplement (including vitamins, calcium tablets, etc.) within 2 weeks before the first dose; Use of birth control pills within two weeks prior to first administration;
Those who have participated in other clinical trials and taken the research drugs within 3 months before the first drug administration;
Blood donation within 3 months before the first drug administration (including component blood donation) or blood loss greater than 400 mL, blood donation within 1 month before screening (including component blood donation) or blood loss greater than 200 mL, or receiving blood transfusion；

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A history of autonomic dysfunction and/or a history of present illness (e.g., recurrent episodes of syncope, palpitations, etc.) within 3 years prior to first administration;
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;
A history of severe vomiting and diarrhea in the previous week;
Female subjects during pregnancy and lactation, and female subjects of child-bearing age who cannot use contraception as required;
Hepatitis B surface antigen positive, hepatitis C2 antibody positive, syphilis antibody positive, HIV antibody positive;
Those who have special dietary requirements and cannot comply with the diet provided and the corresponding regulations;
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;
Subjects refused to stop using any drink or food containing grapefruit 7 days before the first dose until the end of the study;
Difficulty in venous blood collection or inability to tolerate venipuncture;
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.

China1 site

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical College
Nanjing, Jiangsu, 210008

Other trials in China

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 Adult Subjects After Oral Administration of SHR1459 Tablets

The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR1459 tablets.

The secondary objective of the study is to evaluate the safety of single dose of SHR1459 orally in healthy subjects.

Conditions: Healthy Adult Subjects
Being tested: SHR1459 fasted in P1, high-fat diet in P2, SHR1459 high-fat diet in P1, fasted in P2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR1459 fasted in P1, high-fat diet in P2Drug
SHR1459 administration in fasted condition in period 1, SHR1459 administration after high-fat diet in period 2
SHR1459 high-fat diet in P1, fasted in P2Drug
SHR1459 administration after high-fat diet in period 1, SHR1459 administration in fasted condition in period 2

Study groups in NCT04291846
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: SHR1459 fasted in P1, high-fat diet in P2
B	Experimental	Not described Receives: Drug: SHR1459 high-fat diet in P1, fasted in P2

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics parameter: Cmax of SHR1459
Peak Plasma Concentration (Cmax) of SHR1459
Measured: through study completion, an average of 23 days
Pharmacokinetics parameter: AUC of SHR1459
Area under the plasma concentration versus time curve (AUC) of SHR1459
Measured: through study completion, an average of 23 days

Secondary outcomes (11)

Pharmacokinetics parameter: Tmax of SHR1459
Time of maximum observed concentration (Tmax) of SHR1459
Measured: through study completion, an average of 23 days
Pharmacokinetics parameter: T1/2 of SHR1459
Half time (T1/2) of SHR1459
Measured: through study completion, an average of 23 days
Pharmacokinetics parameter: CL/F of SHR1459
Total body clearance for extravascular administration (CL/F) of SHR1459
Measured: through study completion, an average of 23 days
Pharmacokinetics parameter: Vz/F of SHR1459
Volume of distribution (Vz/F) of SHR1459
Measured: through study completion, an average of 23 days
Number of patients with Adverse Events (AEs)
To assess the adverse events according to CTCAE5.0
Measured: through study completion, an average of 23 days
Vital sign (Blood pressure [BP])
To assess the vital signs as a criteria of safety and tolerability variables.
Measured: through study completion, an average of 23 days
Vital sign (pulse)
To assess the vital signs as a criteria of safety and tolerability variables.
Measured: through study completion, an average of 23 days
Vital sign (temperature)
To assess the vital signs as a criteria of safety and tolerability variables.
Measured: through study completion, an average of 23 days
Resting and digital electrocardiograms (ECGs)
To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Measured: through study completion, an average of 23 days
Physical examination
To assess the physical conditions as a criteria of safety and tolerability variables.
Measured: through study completion, an average of 23 days
Laboratory assessments
To assess the hematology, clinical chemistry and urinalysis as a criteria of safety and tolerability variables.
Measured: through study completion, an average of 23 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 202029 Jun 2020

First posted2 Mar 2020
Study start24 May 2020
Primary completion3 Jun 2020
Study completion29 Jun 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: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04291846
Sponsor's protocol ID: SHR1459-I-103
Status last verified: May 2020
First submitted: 25 Feb 2020
Last updated: 27 Jul 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Adult Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 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 Adult Subjects After Oral Administration of SHR1459 Tablets
ClinicalTrials.gov ID: NCT04291846
Acronym / sponsor ID: SHR1459-I-103
Conditions: Healthy Adult Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 24 May 2020 (actual)
Primary completion: 3 Jun 2020 (actual)
Study completion: 29 Jun 2020 (actual)
First posted: 2 Mar 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 adult subjects after oral administration of SHR1459 tablets.

The secondary objective of the study is to evaluate the safety of single dose of SHR1459 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
A	Experimental	Drug: SHR1459 fasted in P1, high-fat diet in P2
B	Experimental	Drug: SHR1459 high-fat diet in P1, fasted in P2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Healthy male or female subjects aged 18 or above (including 18 years old) at the date of signing the informed consent;
Male body weight ≥ 50kg, female body weight ≥ 45kg, 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;
The 12-lead ECG should be normal, with male QTcF < 430ms and female QTcF < 450ms; QTc interval is corrected by Fridericia formula (QTcF = QT/(RR^0.33), RR is the standardized heart rate value, calculated by dividing heart rate by 60);
Negative pregnancy test for women of child-bearing age;

Key exclusion criteria (16 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 12 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= 360 ml beer or 45 ml alcohol content of 40% spirits or 150 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;
Use any prescription drug or herbal tonic within one month before the first dose; Use any over-the-counter (OTC) or food supplement (including vitamins, calcium tablets, etc.) within 2 weeks before the first dose; Use of birth control pills within two weeks prior to first administration;
Those who have participated in other clinical trials and taken the research drugs within 3 months before the first drug administration;

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
SHR1459 fasted in P1, high-fat diet in P2SHR1459 administration in fasted condition in period 1, SHR1459 administration after high-fat diet in period 2	Drug	A
SHR1459 high-fat diet in P1, fasted in P2SHR1459 administration after high-fat diet in period 1, SHR1459 administration in fasted condition in period 2	Drug	B

Primary outcome

Pharmacokinetics parameter: Cmax of SHR1459
Time frame: through study completion, an average of 23 days
Peak Plasma Concentration (Cmax) of SHR1459
Pharmacokinetics parameter: AUC of SHR1459
Time frame: through study completion, an average of 23 days
Area under the plasma concentration versus time curve (AUC) of SHR1459

11 secondary outcomes

Pharmacokinetics parameter: Tmax of SHR1459
Time frame: through study completion, an average of 23 days
Pharmacokinetics parameter: T1/2 of SHR1459
Time frame: through study completion, an average of 23 days
Pharmacokinetics parameter: CL/F of SHR1459
Time frame: through study completion, an average of 23 days
Pharmacokinetics parameter: Vz/F of SHR1459
Time frame: through study completion, an average of 23 days
Number of patients with Adverse Events (AEs)
Time frame: through study completion, an average of 23 days
Vital sign (Blood pressure [BP])
Time frame: through study completion, an average of 23 days
Vital sign (pulse)
Time frame: through study completion, an average of 23 days
Vital sign (temperature)
Time frame: through study completion, an average of 23 days
Resting and digital electrocardiograms (ECGs)
Time frame: through study completion, an average of 23 days
Physical examination
Time frame: through study completion, an average of 23 days
Laboratory assessments
Time frame: through study completion, an average of 23 days

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 27 Jul 2020.
Individual participant dataSharing planned: No

Related trials for Healthy Adult Subjects

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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.

Juan Li, M.D., Ph.D. principal investigator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 16 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 27 Jul 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 SHR1459 (time frame: through study completion, an average of 23 days). 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?

On the ClinicalTrials.gov record for NCT04291846.

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 27 Jul 2020.