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Health, SubjectivePhase 1NCT04455100

A Phase I Study of SHR1459 in Healthy Subjects

A Phase 1 study testing SHR1459/Itraconazole in people with Health, Subjective, 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

Following a 10-hour overnight fast, subjects will be administered one dose of SHR1459 orally with 240 mL of ambient temperature water on Day 1. D2-D3 was the cleaning period. Itraconazole will be administered orally 200 mg/time/day form D4 to D8 after meal. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Health, Subjective
What is being tested?
SHR1459/Itraconazole
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
17 Jul 2020to 14 Aug 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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Sign the informed consent before the trial and fully understand the content, process and possible adverse of the trial;
  • Able and willing to complete research according to the requirements of the trial;
  • Age at the date of signing informed consent 18 to 55 years old (inclusive), male and female;
  • Male body weight ≥50 kg, female body weight ≥45 kg, body mass index (BMI) between ≥18.0 and ≤26.0 kg/m2, inclusive;
  • Health status: lack of medical history of heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities;
  • Comprehensive physical examination (vital signs, physical examination), routine laboratory examination (blood routine, blood biochemistry, urine routine, etc.), X-chest radiograph, abdominal ultrasound (liver, gallbladder, bile duct, spleen, pancreas, kidney), etc, normal or abnormal and no clinical significance;
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  • 12-lead ECG is normal, QTcF for men <430 ms, QTcF for women <450 ms, and heart rate >60;
  • Creatinine clearance (CLCr) ≥80 mL/min, and creatinine is less than or equal to the upper limit of normal value;
  • A negative pregnancy test for females of childbearing potential;
  • Consent to abstinence or use of effective nondrug contraception during the study period and for at least 3 months after the last study drug administration (for women, abstinence or use of effective nondrug contraception during the two weeks prior to study entry is also required).

Who cannot join

  • Blood donation or loss of more than 200 mL of blood within 1 month of screening; or blood donation or loss of more than 400 mL of blood within 3 months of screening; or received blood
  • Allergic constitution, including severe drug allergy or history of drug allergy; history of allergy to SHR1459, itraconazole, or its accessories;
  • Subject has a history of drug abuse in past 5 years or drug abuse in past 3 months, or is positive for drugs of abuse (eg, morphine/methamphetamine/ketamine/ tetrahydrocannabinolic acid /methylenedioxyethylamphetamine );
  • History of regular alcohol and smoke consumption( exceeding or equal an average weekly intake of 14 standard drinks; 1 drink=150 mL of wine or 360 mL of beer or 45 mL of hard liquor; smoke more than or equal to 5 cigarettes per day)or will not refrain from smoking and drinking during the study;
  • History of cardiovascular dysfunction, myocarditis, coronary heart disease, pathological arrhythmia, stroke and other cardiovascular diseases;
  • Lung diseases, including invasive lung disease, pneumonia, dyspnea, etc;
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  • History of chronic kidney disease, renal insufficiency, renal anemia;
  • History of dysphagia or any gastrointestinal disease that affects drug absorption;
  • Any uncontrolled peptic ulcer, colitis, pancreatitis, etc;
  • Had a surgery within 6 months of screening;
  • Important organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and skeletal muscle system (such as uncontrolled diabetes, hypertension, etc.), in the investigator's judgment it is not suitable to participate in this trial;
  • Have taken hepatotoxic drugs for a long period of time (more than 2 consecutive weeks) (such as acetaminophen, statin lipid-lowering drugs, azithromycin, dapsone, clarithromycin, fluconazole, ketoconazole) before the screening;
  • Participated in other clinical trials or used drugs related to this trial within 3 months before screening;
  • Have taken any drugs that alter the activity of liver enzymes 28 days before or during the study;
  • Have taken any prescription or over-the-counter medicine 14 days before study drug administration;
  • Have taken any vitamin products or herbs 14 days before study drug administration;
  • Evidence of clinically significant or other clinical findings show the following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardio-cerebrovascular diseases);
  • Combine with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or syphilis infection;
  • Have ingested grapefruit or products containing grapefruit, dragon fruit, mango, lime, carambola, or food or beverage prepared therefrom 48 hours before taking the study drug;, food or beverage containing caffeine, xanthine or alcohol (Including chocolate, tea, coffee, cola, etc.); strenuous exercise, or other factors that affect the absorption, distribution, metabolism, excretion of drugs, etc;
  • According to the screening chest X-ray and abdominal ultrasound (liver, gallbladder, bile duct, spleen, pancreas, kidney) examination items confirmed abnormal and clinically significant;
  • Vaccination recipients within 4 weeks before screening;
  • Cannot tolerate venous puncture or have a history of halo acupuncture;
  • Lactose intolerant;
  • Required special dietary and refuse the unified diet;
  • Subjects with acute illness from screening to pre-dose;
  • In the investigator's judgment subjects are not suitable to participate in this trial;
  • In addition to the above requirements, female volunteers who meet the following conditions should also be excluded:
  • Have taken contraceptives within 30 days before screening (interview);
  • Used long-acting estrogen or progesterone injections (including progesterone intrauterine devices) or implants within 6 months before screening;
  • Subjects had unprotected sex with their partner within 14 days before screening;
  • Female subjects are during in period of lactating.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

Other trials in China

About this study

Official title: Open-Label, Single-Center, Single-arm, Fixed Sequence Study on the Effect of Itraconazole on the Pharmacokinetics of SHR1459 in Health Subjects

Following a 10-hour overnight fast, subjects will be administered one dose of SHR1459 orally with 240 mL of ambient temperature water on Day 1. D2-D3 was the cleaning period. Itraconazole will be administered orally 200 mg/time/day form D4 to D8 after meal. On D7 following a 10-hour overnight fast, subjects will be administered SHR1459 and itraconazole 200 mg with 240 mL of ambient temperature water.

Being tested
SHR1459/Itraconazole

What participants receive

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

  • SHR1459/ItraconazoleDrug

    SHR1459 will be administered on Day 1 and Day 7. Itraconazole will be administered on Day 4 to Day 8

Study groups in NCT04455100
Study groupRoleWhat they receive
SHR1459ExperimentalFollowing a 10-hour overnight fast, subjects will be administered one dose of SHR1459 orally with 240 mL of ambient temperature water on Day 1. D2-D3 was the cleaning period. Itraconazole will be administered orally 200 mg/time/day form D4 to D8 after meal. On D7 following a 10-hour overnight fast, subjects will be administered SHR1459 and itraconazole 200 mg with 240 mL of ambient temperature water.
Receives: Drug: SHR1459/Itraconazole

What is being measured

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

  1. Pharmacokinetics parameter: Cmax of SHR1459

    Peak Plasma Concentration (Cmax) of SHR1459

    Measured: from Day 1 to Day 9

  2. Pharmacokinetics parameter: AUC of SHR1459

    Area under the plasma concentration versus time curve (AUC) of SHR1459

    Measured: from Day 1 to Day 9

Secondary outcomes (4)

  1. Pharmacokinetics parameter: Tmax of SHR1459

    Time of maximum observed concentration (Tmax) of SHR1459

    Measured: from Day 1 to Day 9

  2. Pharmacokinetics parameter: T1/2 of SHR1459

    Half time (T1/2) of SHR1459

    Measured: from Day 1 to Day 9

  3. Pharmacokinetics parameter: CL/F of SHR1459

    Apparent clearance of SHR1459

    Measured: from Day 1 to Day 9

  4. Pharmacokinetics parameter: Vz/F of SHR1459

    Apparent volume of distribution of SHR1459

    Measured: from Day 1 to Day 9

Timeline

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

  1. First posted2 Jul 2020
  2. Study start17 Jul 2020
  3. Primary completion14 Aug 2020
  4. Study completion14 Aug 2020

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04455100
Sponsor's protocol ID
SHR1459-I-106
Status last verified
Oct 2021
First submitted
27 Jun 2020
Last updated
18 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR1459/Itraconazole in people with Health, Subjective, 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 31 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 SHR1459 (time frame: from Day 1 to Day 9). 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 NCT04455100.

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.

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