Healthy SubjectsPhase 1NCT04439578
Effect of Rifampicin on the Pharmacokinetics of SHR6390 in Healthy Subjects
A Phase 1 study testing SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin in people with Healthy 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 rifampicin on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with rifampicin. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2020to 15 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
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);
- Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form to the date of the last medication. Serum HCG test of fertile women before the study must be negative
- Physical examination (vital signs, physical examination), routine laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram, orthotopic chest X-ray and abdominal B-ultrasound are normal or abnormal but have no clinical significance
Who cannot join
- Allergic constitution;
- History of drug use, or drug abuse screening positive;
- Alcoholic or often drinkers;
- Left ventricular ejection fraction (LVEF) <50% by echocardiography;
- A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
- Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
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- Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening.
- Patients who have had any surgery and taken hepatotoxic drugs in the previous 6 months before screening.
- Patients who use any vitamin product or herb 14 days prior to screening.
- HCV positive, HIV antibody positive, HBsAg positive, syphilis antibody positive.
- Subjects who are considered unfit to participate in the study by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of SHR6390 in Healthy Chinese Adult Subjects.
The primary objective of the study is to evaluate the effect of rifampicin on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with rifampicin.
- Conditions
- Healthy Subjects
- Being tested
- SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicinDrug
Also called rifampicin
600 mg rifampicin was administered in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | subjects receiving a single oral dose of SHR6390 tablets, then rifampicin capsules 600 mg/day orally with a single oral dose of SHR6390 tablets co-administered. Receives: Drug: SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameter: Cmax of SHR6390
Peak Plasma Concentration (Cmax) of SHR6390
Measured: through study completion, an average of 32 days
Pharmacokinetics parameter: AUC of SHR6390
Area under the plasma concentration versus time curve (AUC) of SHR6390
Measured: through study completion, an average of 32 days
Secondary outcomes (2)
Pharmacokinetics parameter: Tmax of SHR6390
Time of maximum observed concentration (Tmax) of SHR6390
Measured: :through study completion, an average of 32 days
Pharmacokinetics parameter: T1/2 of SHR6390
Half time (T1/2) of SHR6390
Measured: through study completion, an average of 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start23 Jun 2020
- Primary completion17 Aug 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT04439578
- Sponsor's protocol ID
- SHR6390-I-107
- Status last verified
- Oct 2021
- First submitted
- 18 Jun 2020
- Last updated
- 18 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of SHR6390 in Healthy Chinese Adult Subjects.
- ClinicalTrials.gov ID
- NCT04439578
- Acronym / sponsor ID
- SHR6390-I-107
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 19 Jun 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 rifampicin on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with rifampicin.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicinsubjects receiving a single oral dose of SHR6390 tablets, then rifampicin capsules 600 mg/day orally with a single oral dose of SHR6390 tablets co-administered. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);
- Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form to the date of the last medication. Serum HCG test of fertile women before the study must be negative
Key exclusion criteria (11 listed)
- Allergic constitution;
- History of drug use, or drug abuse screening positive;
- Alcoholic or often drinkers;
- Left ventricular ejection fraction (LVEF) <50% by echocardiography;
- A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
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 |
|---|---|---|
| SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicinAlso: rifampicin600 mg rifampicin was administered in the morning. | Drug | Treatment |
Primary outcome
Pharmacokinetics parameter: Cmax of SHR6390
Time frame: through study completion, an average of 32 days
Peak Plasma Concentration (Cmax) of SHR6390
Pharmacokinetics parameter: AUC of SHR6390
Time frame: through study completion, an average of 32 days
Area under the plasma concentration versus time curve (AUC) of SHR6390
2 secondary outcomes
Pharmacokinetics parameter: Tmax of SHR6390
Time frame: :through study completion, an average of 32 days
Pharmacokinetics parameter: T1/2 of SHR6390
Time frame: through study completion, an average of 32 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 18 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 tablet single oral dose of SHR6390 or co-administered with rifampicin in people with Healthy 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 6 inclusion and 11 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 18 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?
Pharmacokinetics parameter: Cmax of SHR6390 (time frame: through study completion, an average of 32 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?
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 18 Oct 2021.