Healthy VolunteersPhase 1NCT04667156

Study to Investigate Relative Bioavailability of Different Formulations of SHR6390 in Healthy Subjects

A Phase 1 study testing SHR6390 in people with Healthy Volunteers, 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 purpose of this study is to investigate relative bioavailability during the new and traditional formulations of SHR6390 in healthy subjects Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: SHR6390
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 13 Dec 2020to 29 Jan 2021
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Execute an informed consent;
Male or female aged 18-45 years (including threshold) on the date of signing the informed consent;
Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value);
Physical examination, vital signs, laboratory examination , 12-Lead ECG, abdominal B-ultrasound, chest X-ray, etc. are normal or abnormal, but the researcher has no clinical significance according to NCI CTCAE 5.0 standard;
Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 7 months from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women within 72 hours before the first administration of the study drug should be negative.

Who cannot join

Those who have previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, which are judged by the researchers to be unsuitable for the trial;
Patients who have received any previous operation affecting gastrointestinal absorption;
Patients who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
HBsAg positive, HCV antibody positive, HIV antibody positive, syphilis antibody positive;
History of drug use or drug abuse, or drug screening positive;

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Smoking and alcohol addict and unable to stop smoking during the test period; those with positive alcohol screening; those with positive nicotine screening;
Allergic constitution, including severe drug allergy or drug allergy history; known allergy to shr6390 tablets or its excipients;
Having swallowing resistance or disorder, affecting drug absorption;
Participated in other clinical trials and taken the study drug within 3 months before taking the study drug for the first time;
Inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C8 were taken within 4 weeks before the first administration of study drug;
Taking any prescription drug, over-the-counter drug, traditional Chinese medicine or food supplement within 2 weeks before taking the study drug for the first time;
Ingestion of grapefruit containing products, fruit juice, food or beverage containing methylxanthine or alcohol within 72 hours before taking the study drug for the first time; taking strenuous exercise; or having other factors affecting the absorption, distribution, metabolism and excretion of drugs;
Lactating women;
The researchers considered that the subjects had any other factors that were not suitable for the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 470071

Other trials in China

About this study

Official title: A Single-centre, Single Dose, Randomized, Open-label, Three Period, Six Sequence, Cross Controlled Study to Assess the Relative Bioavailability of the New and Traditional Formulations on SHR6390 in Healthy Subjects

The purpose of this study is to investigate relative bioavailability during the new and traditional formulations of SHR6390 in healthy subjects

Conditions: Healthy Volunteers
Being tested: SHR6390

What participants receive

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

SHR6390Drug
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles

Study groups in NCT04667156
Study group	Role	What they receive
Sequence 1	Experimental	Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 traditional formulation (R) in the last period Receives: Drug: SHR6390
Sequence 2	Experimental	Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 new formulation 2 (T2) in the last period Receives: Drug: SHR6390
Sequence 3	Experimental	Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 1 (T1) in the last period Receives: Drug: SHR6390
Sequence 4	Experimental	Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 2 (T2) in the last period Receives: Drug: SHR6390
Sequence 5	Experimental	Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 traditional formulation (R) in the last period Receives: Drug: SHR6390
Sequence 6	Experimental	Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 new formulation 1 (T1) in the last period Receives: Drug: SHR6390

What is being measured

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

Fr
Relative bioavailability of the two new formulations on SHR6390
Measured: Day1~Day35
Cmax
Maximum concentration of SHR6390
Measured: Day1~Day35
AUC0-t
Area under the concentration-time curve from time zero to time t of SHR6390
Measured: Day1~Day35
AUC0-∞
Area under the concentration-time curve extrapolated to infinity of SHR6390
Measured: Day1~Day35

Timeline

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

13 Dec 202029 Jan 2021

First posted14 Dec 2020
Study start13 Dec 2020
Primary completion29 Jan 2021
Study completion29 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04667156
Sponsor's protocol ID: SHR6390-I-112
Status last verified: Oct 2021
First submitted: 2 Dec 2020
Last updated: 12 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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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Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-centre, Single Dose, Randomized, Open-label, Three Period, Six Sequence, Cross Controlled Study to Assess the Relative Bioavailability of the New and Traditional Formulations on SHR6390 in Healthy Subjects
ClinicalTrials.gov ID: NCT04667156
Acronym / sponsor ID: SHR6390-I-112
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 13 Dec 2020 (actual)
Primary completion: 29 Jan 2021 (actual)
Study completion: 29 Jan 2021 (actual)
First posted: 14 Dec 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 purpose of this study is to investigate relative bioavailability during the new and traditional formulations of SHR6390 in healthy subjects

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1	Experimental	Drug: SHR6390Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 traditional formulation (R) in the last period
Sequence 2	Experimental	Drug: SHR6390Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 new formulation 2 (T2) in the last period
Sequence 3	Experimental	Drug: SHR6390Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 1 (T1) in the last period
Sequence 4	Experimental	Drug: SHR6390Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 2 (T2) in the last period
Sequence 5	Experimental	Drug: SHR6390Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 traditional formulation (R) in the last period
Sequence 6	Experimental	Drug: SHR6390Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 new formulation 1 (T1) in the last period

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Execute an informed consent;
Male or female aged 18-45 years (including threshold) on the date of signing the informed consent;
Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value);
Physical examination, vital signs, laboratory examination , 12-Lead ECG, abdominal B-ultrasound, chest X-ray, etc. are normal or abnormal, but the researcher has no clinical significance according to NCI CTCAE 5.0 standard;
Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 7 months from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women within 72 hours before the first administration of the study drug should be negative.

Key exclusion criteria (15 listed)

Those who have previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, which are judged by the researchers to be unsuitable for the trial;
Patients who have received any previous operation affecting gastrointestinal absorption;
Patients who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
HBsAg positive, HCV antibody positive, HIV antibody positive, syphilis antibody positive;

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
SHR6390SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

Fr
Time frame: Day1~Day35
Relative bioavailability of the two new formulations on SHR6390
Cmax
Time frame: Day1~Day35
Maximum concentration of SHR6390
AUC0-t
Time frame: Day1~Day35
Area under the concentration-time curve from time zero to time t of SHR6390
AUC0-∞
Time frame: Day1~Day35
Area under the concentration-time curve extrapolated to infinity of SHR6390

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 12 Oct 2021.
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.

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 SHR6390 in people with Healthy Volunteers, 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 15 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 12 Oct 2021. 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?

Fr (time frame: Day1~Day35). The study lists 4 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 NCT04667156.

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 12 Oct 2021.