Malignant TumorPhase 1NCT05661591

Effect of Fluconazole on Pharmacokinetics of SHR2554 in Healthy Subjects

A Phase 1 study testing SHR2554 Tablets and Fluconazole Capsules in people with Malignant Tumor, 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 study is being conduct to evaluate fluconazole effect of on SHR2554 in condition of single-canter, open-label, single-dose in healthy subjects. To explore the SHR2554 pharmacokinetics change under use of fluconazole and insure the safety with SHR2554 combined with fluconazole. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Malignant Tumor
What is being tested?: SHR2554 Tablets and Fluconazole Capsules
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: 28 Feb 2023to 31 Mar 2023
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 form before the trial, fully understand the trial process and possible adverse reactions in trail, and be able to complete the research in accordance with the requirements of the trail protocol;
Healthy male and female subjects aged 18 to 45 year the date of signing the informed consent form, with female subjects ratio is not less than 40%;
Male subjects weighed ≥ 50kg, female subjects weighed ≥ 45kg, and body mass index (BMI) was in the range of 19.0~26.0kg/m2 (including the cut-off value);
No family plan for the next 30 days and voluntary use of highly effective contraception during the trial.

Who cannot join

Allergies, including severe drug allergies or drug allergies; history of allergy to SHR2554 tablets, fluconazole capsules, or their excipients;
A clear history of primary diseases of important organs such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolic and musculoskeletal system, including but not limited to tumour patients or tumour history, which the investigator believes is not suitable to participate in this study;
During screening, comprehensive physical examination, vital signs examination (breathing, blood pressure, pulse and body temperature), chest orthostatic X-ray, and laboratory tests (blood biochemistry, blood routine, urine routine, immunization eight, coagulation function, female pregnancy) and other abnormal clinical significance (subject to the judgment of the clinician);
Screening of male QTcF ≥ 430 msec or female QTcF ≥ 450 msec by electrocardiogram examination, or abnormal clinical significance judged by the investigator in the ECG results;
Have a history of drug and/or alcohol abuse, positive alcohol and drug screening, or have a history of drug abuse within the past five years or have used drugs in the 3 months before the trail;
Addicts to tobacco and alcohol (drinking ≥ 14 units of alcohol per week) in the 3 months before screening: 1 unit = 360mL of beer, or 45mL of spirits, or 150mL of wine; Those who smoke ≥5 cigarettes) daily and cannot ban smoking and alcohol during the test;

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Those who have undergone any surgery within 6 months before screening;
Hepatotoxic drugs (such as itraconazole, dapsone, erythromycin, fluconazole, ketoconazole, rifampicin, isoniazid, tetracycline, glibenclamide, propylthiouracil, methimazole, statin lipid-lowering drugs, fenofibrate, etc.) within 6 months before screening;
Use of any drugs that alter the activity of CYP3A enzyme (such as carbamazepine, phenytoin, modafinil, ritonavir, voriconazole, St. John's wort, bosentan tablets, efavirenz, etravirine, ciprofloxacin, etc.) within 28 days before taking the study drug;
Use of any prescription drug, over-the-counter drug, vitamin product, supplement or herbal medicine within 14 days before taking the trail drug;
ingested grapefruit or grapefruit-containing products, caffeinated, xanthine, or alcoholic foods or beverages within 48 hours prior to taking the study drug; strenuous exercise, or other factors that affect drug absorption, distribution, metabolism, excretion and other factors;
Those who participated in blood donation within 3 months before taking the study drug and donated blood ≥ 200mL, or received blood transfusion;
Those with a history of needle sickness and blood sickness, difficulty in blood collection or inability to tolerate venous puncture blood collection;
female subjects lactating; Male subjects who have a sperm donation plan from the signing of the informed consent form until 30 days after the last dose of the experimental drug;
Those who have participated in other drug trials within 3 months before screening;
participants who the investigator believes have other factors that are not suitable for participation in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: Pharmacokinetic Effect of Fluconazole on SHR2554 in Healthy Subjects in Single-center, Open-label, Single-dose, Auto-controlled Pharmacokinetics

Conditions: Malignant Tumor
Being tested: SHR2554 Tablets, Fluconazole Capsules
Medical subject headings: Neoplasms

What participants receive

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

SHR2554 TabletsDrug
SHR2554 Tablets+ Fluconazole Capsules
Fluconazole CapsulesDrug
SHR2554 Tablets+ Fluconazole Capsules

Study groups in NCT05661591
Study group	Role	What they receive
Treatment group A	Experimental	SHR2554+ Fluconazole Capsules Receives: Drug: SHR2554 Tablets; Drug: Fluconazole Capsules

What is being measured

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

Pharmacokinetic parameters of SHR2554: Cmax
Measured: day 1 to day 10
Pharmacokinetic parameters of SHR2554: AUC0-t
Measured: day 1 to day 10
Pharmacokinetic parameters of SHR2554: AUC0-∞
Measured: day 1 to day 10

Secondary outcomes (5)

Pharmacokinetic parameters of SHR2554: Tmax
Measured: day 1 to day 10
Pharmacokinetic parameters of SHR2554: t1/2
Measured: day 1 to day 10
Pharmacokinetic parameters of SHR2554: CL/F
Measured: day 1 to day 10
Pharmacokinetic parameters of SHR2554: Vz/F
Measured: day 1 to day 10
The incidence and severity of adverse events/serious adverse events
Measured: from ICF signing date to approximate day 18

Timeline

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

28 Feb 202331 Mar 2023

First posted22 Dec 2022
Study start28 Feb 2023
Primary completion31 Mar 2023
Study completion31 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Malignant TumorStudies 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: Not applicable
Intervention model: Single group
Model description: Single-center, open-label, single-dose, self-control
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05661591
Sponsor's protocol ID: SHR2554-I-110
Status last verified: Apr 2023
First submitted: 15 Dec 2022
Last updated: 4 Apr 2023
Results posted: 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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All Malignant Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic Effect of Fluconazole on SHR2554 in Healthy Subjects in Single-center, Open-label, Single-dose, Auto-controlled Pharmacokinetics
ClinicalTrials.gov ID: NCT05661591
Acronym / sponsor ID: SHR2554-I-110
Conditions: Malignant Tumor
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: 28 Feb 2023 (actual)
Primary completion: 31 Mar 2023 (actual)
Study completion: 31 Mar 2023 (actual)
First posted: 22 Dec 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single-center, open-label, single-dose, self-control

Arm	Type	Receives
Treatment group A	Experimental	Drug: SHR2554 Tablets, Drug: Fluconazole CapsulesSHR2554+ Fluconazole Capsules

Who may qualify

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

Key inclusion criteria (4 listed)

Sign the informed consent form before the trial, fully understand the trial process and possible adverse reactions in trail, and be able to complete the research in accordance with the requirements of the trail protocol;
Healthy male and female subjects aged 18 to 45 year the date of signing the informed consent form, with female subjects ratio is not less than 40%;
Male subjects weighed ≥ 50kg, female subjects weighed ≥ 45kg, and body mass index (BMI) was in the range of 19.0~26.0kg/m2 (including the cut-off value);
No family plan for the next 30 days and voluntary use of highly effective contraception during the trial.

Key exclusion criteria (16 listed)

Allergies, including severe drug allergies or drug allergies; history of allergy to SHR2554 tablets, fluconazole capsules, or their excipients;
A clear history of primary diseases of important organs such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolic and musculoskeletal system, including but not limited to tumour patients or tumour history, which the investigator believes is not suitable to participate in this study;
During screening, comprehensive physical examination, vital signs examination (breathing, blood pressure, pulse and body temperature), chest orthostatic X-ray, and laboratory tests (blood biochemistry, blood routine, urine routine, immunization eight, coagulation function, female pregnancy) and other abnormal clinical significance (subject to the judgment of the clinician);
Screening of male QTcF ≥ 430 msec or female QTcF ≥ 450 msec by electrocardiogram examination, or abnormal clinical significance judged by the investigator in the ECG results;
Have a history of drug and/or alcohol abuse, positive alcohol and drug screening, or have a history of drug abuse within the past five years or have used drugs in the 3 months before the trail;

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
SHR2554 TabletsSHR2554 Tablets+ Fluconazole Capsules	Drug	Treatment group A
Fluconazole CapsulesSHR2554 Tablets+ Fluconazole Capsules	Drug	Treatment group A

Primary outcome

Pharmacokinetic parameters of SHR2554: Cmax
Time frame: day 1 to day 10
Pharmacokinetic parameters of SHR2554: AUC0-t
Time frame: day 1 to day 10
Pharmacokinetic parameters of SHR2554: AUC0-∞
Time frame: day 1 to day 10

5 secondary outcomes

Pharmacokinetic parameters of SHR2554: Tmax
Time frame: day 1 to day 10
Pharmacokinetic parameters of SHR2554: t1/2
Time frame: day 1 to day 10
Pharmacokinetic parameters of SHR2554: CL/F
Time frame: day 1 to day 10
Pharmacokinetic parameters of SHR2554: Vz/F
Time frame: day 1 to day 10
The incidence and severity of adverse events/serious adverse events
Time frame: from ICF signing date to approximate day 18

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 4 Apr 2023.
Individual participant dataSharing planned: Undecided

Related trials for Malignant Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

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 Tablets and Fluconazole Capsules in people with Malignant Tumor, 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 4 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 4 Apr 2023. 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?

Pharmacokinetic parameters of SHR2554: Cmax (time frame: day 1 to day 10). 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 NCT05661591.

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 4 Apr 2023.