Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, SHR1459Phase 1NCT04649723

Drug-Drug Interaction of SHR1459 With a Strong CYP3A Index Inducer (Rifampicin)

A Phase 1 study testing Rifampin and SHR1459 in people with Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, SHR1459, 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

This drug-drug interaction (DDI) study had been designed to investigate the effect of a strong CYP 3A index fan-inducer rifampicin on the pharmacokinetics of SHR1459 in Chinese healthy volunteers. 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, Drug-drug Interaction, Pharmacokinetics, SHR1459
What is being tested?: Rifampin and SHR1459
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: 24 Nov 2020to 14 Dec 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 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;
Body weight ≥50 kg for male and≥ 45 kg for female, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);
In females, documented surgical sterilization, postmenopausal status for at least 1 year (follicle stimulating hormone [FSH] > 40 mIU/mL serum at Screening), or agreement to use an approved form of contraception
In males, agreement to avoid sperm donation for 3 months days after the dose of SHR1459

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Liver function test results must be below the upper limit of normal.
Participants must agree to refrain from donation of whole blood and other blood products from 90 days prior to screening.
Heart rate ≥60 bpm.
GFR≥90 mL/min/1.73m2.

Who cannot join

Loss of more than 400 mL blood during the 3 months before the trial (eg, as a blood donor)
Allergic constitution;
History of drug use, or drug abuse screening positive;
Alcoholic or often drinkers;
A smoker with 5 cigarettes per day for more than 90 days;
Positive serology for hepatitis B surface antigen (HBsAg) and HCV (healthy participants), anti-treponema pallidum virus (TP), or antihuman immunodeficiency virus (HIV) Type 1 and Type 2 (all subjects)

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Use of any drugs or substances known to be inhibitors or inducers of CYP3A within 90 days from the first dose or 5 half-lives, if known, of the drugs or substances, whichever is greater, prior to SHR1459 administration and during the study.
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.
Use of grapefruit or marmalade in 2 weeks prior to admission to the clinical unit, as reported by the subject.
Major surgery within 6 months before screening.
Woman in breastfeeding and pregnancy and with egg donation plan, and man with sperm donation plan in 6 months after follow-up in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu HengRui Medicine Co., Ltd.
Shanghai, Shanghai Municipality, 201203

Other trials in China

About this study

Official title: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Phase I Drug-Drug Interaction Clinical Study of the Effect of Rifampicin on Pharmacokinetics of SHR1459 in Chinese Healthy Subjects.

This drug-drug interaction (DDI) study had been designed to investigate the effect of a strong CYP 3A index fan-inducer rifampicin on the pharmacokinetics of SHR1459 in Chinese healthy volunteers.

Conditions: Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, SHR1459
Being tested: Rifampin, SHR1459

What participants receive

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

RifampinDrug
single oral dose, 600 mg, fasted.
SHR1459Drug
single oral dose, 200 mg, fasted.

Study groups in NCT04649723
Study group	Role	What they receive
Rifampicin 600 mg + SHR1459 Tablets 200 mg	Experimental	Not described Receives: Drug: Rifampin; Drug: SHR1459
SHR1459 tablets 200 mg	Active comparator	Not described Receives: Drug: SHR1459

What is being measured

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

Maximum Plasma Concentration (Cmax) for SHR1459.
Measured: predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9
Area Under the Plasma Concentration-time Curve from 0 to any time before the last quantifiable concentration (AUC0-t) for SHR1459.
Measured: predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9
Area Under the Plasma Concentration-time Curve from 0 to infinite time (AUCinf) for SHR1459.
Measured: predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9

Secondary outcomes (2)

Other pharmacokinetics parameters of SHR1459: Tmax, T1/2, CL, Vd, etc
Measured: predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9
The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0): Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination, vital signs, etc.
Measured: Baseline up to 14 days post last dose, up to approximately 2 month

Timeline

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

24 Nov 202014 Dec 2020

First posted2 Dec 2020
Study start24 Nov 2020
Primary completion14 Dec 2020
Study completion14 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, SHR1459Studies 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: Non-randomised
Intervention model: Sequential
Model description: To observe the effect of rifampicin on the pharmacokinetics of SHR1459 and to evaluate the safety of SHR1459, rifampicin and their coadministration in Chinese healthy subjects. The subjects will take SHR1459 at first single dose, then washout period, and take it at second single dose after multiple administration of rifampicin to get a full induction condition.
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04649723
Sponsor's protocol ID: SHR1459-I-105
Status last verified: Nov 2020
First submitted: 10 Nov 2020
Last updated: 11 Jan 2021
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 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Phase I Drug-Drug Interaction Clinical Study of the Effect of Rifampicin on Pharmacokinetics of SHR1459 in Chinese Healthy Subjects.
ClinicalTrials.gov ID: NCT04649723
Acronym / sponsor ID: SHR1459-I-105
Conditions: Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, SHR1459
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: 24 Nov 2020 (actual)
Primary completion: 14 Dec 2020 (actual)
Study completion: 14 Dec 2020 (actual)
First posted: 2 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.

This drug-drug interaction (DDI) study had been designed to investigate the effect of a strong CYP 3A index fan-inducer rifampicin on the pharmacokinetics of SHR1459 in Chinese healthy volunteers.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: To observe the effect of rifampicin on the pharmacokinetics of SHR1459 and to evaluate the safety of SHR1459, rifampicin and their coadministration in Chinese healthy subjects. The subjects will take SHR1459 at first single dose, then washout period, and take it at second single dose after multiple administration of rifampicin to get a full induction condition.

Arm	Type	Receives
Rifampicin 600 mg + SHR1459 Tablets 200 mg	Experimental	Drug: Rifampin, Drug: SHR1459
SHR1459 tablets 200 mg	Active comparator	Drug: SHR1459

Who may qualify

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

Key inclusion criteria (10 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;
Body weight ≥50 kg for male and≥ 45 kg for female, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);
In females, documented surgical sterilization, postmenopausal status for at least 1 year (follicle stimulating hormone [FSH] > 40 mIU/mL serum at Screening), or agreement to use an approved form of contraception

Key exclusion criteria (12 listed)

Loss of more than 400 mL blood during the 3 months before the trial (eg, as a blood donor)
Allergic constitution;
History of drug use, or drug abuse screening positive;
Alcoholic or often drinkers;
A smoker with 5 cigarettes per day for more than 90 days;

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
Rifampinsingle oral dose, 600 mg, fasted.	Drug	Rifampicin 600 mg + SHR1459 Tablets 200 mg
SHR1459single oral dose, 200 mg, fasted.	Drug	Rifampicin 600 mg + SHR1459 Tablets 200 mg, SHR1459 tablets 200 mg

Primary outcome

Maximum Plasma Concentration (Cmax) for SHR1459.
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9
Area Under the Plasma Concentration-time Curve from 0 to any time before the last quantifiable concentration (AUC0-t) for SHR1459.
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9
Area Under the Plasma Concentration-time Curve from 0 to infinite time (AUCinf) for SHR1459.
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9

2 secondary outcomes

Other pharmacokinetics parameters of SHR1459: Tmax, T1/2, CL, Vd, etc
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9
The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0): Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination, vital signs, etc.
Time frame: Baseline up to 14 days post last dose, up to approximately 2 month

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 11 Jan 2021.
Individual participant dataSharing planned: No

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 Rifampin and SHR1459 in people with Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, SHR1459, 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 10 inclusion and 12 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 11 Jan 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?

Maximum Plasma Concentration (Cmax) for SHR1459. (time frame: predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9). 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?

On the ClinicalTrials.gov record for NCT04649723.

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 11 Jan 2021.