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HealthyPhase 1NCT02749097

A PHASE I, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE DOSE ESCALATION STUDY TO INVESTIGATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SHR0534 IN HEALTHY VOLUNTEERS

A Phase 1 study testing SHR0534 in people with Healthy, run by Jiangsu HengRui Medicine Co., Ltd..

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 is a randomized, placebo-controlled, single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with starting dose of 10 mg followed by dose escalation groups up to 200 mg. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
SHR0534
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
No sites listed yet
Study dates
Oct 2013to Dec 2013
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject must be adequately informed of the nature and risks of the study, able to understand the risks associated with the study, and are willing to provide written informed consent prior to screening.
  • Must have be at least 50 kg (110 lb), and a BMI between 19.0 to 32.0 kg/m2, inclusive.
  • Drug screen (including alcohol) must have been negative at Screening and on admission to study site.
  • Subjects must be free of any clinically significant diseases based on medical history , physical examination and/or the investigator's judgment
  • Clinical laboratory tests (i.e. CBC, platelet count, blood chemistries, and urinalysis) must be within the normal reference range or clinically acceptable as determined by the investigator.
  • Completion of the screening process within 14 days prior to dosing.
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  • Must be able to communicate effectively with the study personnel.
  • Must be nonsmokers, defined as not having smoked tobacco or used chewing tobacco or nicotine-containing products in the 6 months prior to Day 1. Cotinine test must be negative at Screening and Day -1.
  • Must have, in the investigator's opinion, no clinically significant diseases or abnormal laboratory test values as determined by medical and psychiatric history, physical examination, or laboratory evaluations conducted at the screening visit or on clinic admission.
  • Subjects of reproductive potential with partners who are women of childbearing potential, will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 90 days after discontinuing treatment with the investigational product. Highly effective methods of birth control include sexual abstinence, vasectomy or a condom with spermicide (men) in combination with barrier methods, oral, injected, or implanted hormonal birth control methods, or placement of an intrauterine device or intrauterine system (for female partner).
  • Subjects must agree not to donate sperm during the study and for 90 days after discontinuing treatment with the investigational product.

Who cannot join

  • History of hypersensitivity to SHR0534 or its components.
  • History of or current clinically important systemic illnesses, including but not limited to cardiovascular, pulmonary, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological, neurological, or psychiatric diseases, or any conditions that may place the subject at increased risk as determined by the investigator.
  • Any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • History of surgery or major trauma within 12 weeks of study entry, or surgery planned during the study.
  • History of allergy or hypersensitivity to heparin, or heparin-induced thrombocytopenia.
  • History of myocardial infarction, stroke or sudden unexplained death in a first degree family member under the age of 60 years.
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  • History of liver disease. Those with ALT or AST >1.5 times upper limit of normal must be excluded.
  • Subjects with anemia or abnormal hematology parameters with clinically significance as determined by the investigator must be excluded.
  • History or presence of clinically significant electrocardiogram (ECG) abnormalities.
  • History of alcohol dependent, habitual heavy users of caffeinated beverages judged by the investigator.
  • Have used any alcohol-containing products within 3 days of Day 1.
  • Urine drug screen test positive for ethanol, cocaine, tetrahydrocannabinol (THC), barbiturates, amphetamines, benzodiazepines, or opiates.
  • Have used any drugs or substances (including herbal supplements) known to inhibit or induce cytochrome (CYP) P450 enzymes including CYP3A4, CYP2C8 and CYP2C9 within 28 days prior to the first dose and throughout the study.
  • Use of any over-the-counter (OTC), nutraceuticals, or prescription medications (except as specified within this protocol) within 7 days or 5 half lives (whichever is longer), prior to receiving investigational product. By exception, up to 2 g per day acetaminophen (paracetamol) for analgesia will be allowed up to 48 hours prior to Day -1.
  • Use of xanthine-containing substances, or alcohol-containing products within 48 hours prior to study drug administration.
  • Use of grapefruit or related citrus fruit products 7 days prior to the study drug administration or intend to use during the study.
  • Have taken other investigational drugs or participated in any clinical trial within 30 days prior to first dose of study drug in this study.
  • Have had significant blood loss (>450 mL) or have donated 1 or more units of blood or plasma within 12 weeks prior to study entry.
  • Have a positive test at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb).
  • Have any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.
  • Any individual involved in the planning or conduct of this study.

About this study

This is a randomized, placebo-controlled, single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with starting dose of 10 mg followed by dose escalation groups up to 200 mg. Eight subjects will be randomized in 3:1 ratio in each cohort to receive the study drug or placebo.

Conditions
Healthy
Being tested
SHR0534, Placebo

What participants receive

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

  • SHR0534Drug

  • PlaceboDrug

Study groups in NCT02749097
Study groupRoleWhat they receive
Cohort 1ExperimentalSingle oral dose of 10 mg SHR0534 or matching placebo
Receives: Drug: SHR0534; Drug: Placebo
Cohort 2ExperimentalSingle oral dose of 25 mg SHR0534 or matching placebo
Receives: Drug: SHR0534; Drug: Placebo
Cohort 3ExperimentalSingle oral dose of 50 mg SHR0534 or matching placebo
Receives: Drug: SHR0534; Drug: Placebo
Cohort 4ExperimentalSingle oral dose of 100 mg SHR0534 or matching placebo
Receives: Drug: SHR0534; Drug: Placebo
Cohort 5ExperimentalSingle oral dose of 200 mg SHR0534 or matching placebo
Receives: Drug: SHR0534; Drug: Placebo

What is being measured

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

  1. Number of treatment emergent adverse events (TEAEs)

    Measured: From baseline up to 8 days after single dose

Secondary outcomes (4)

  1. Area under the plasma concentration curve (AUC)

    Measured: From time 0 to 168 hours after single dose

  2. Peak plasma concentration (Cmax) after dose after dose

    Measured: From time 0 to 168 hours after single dose

  3. Terminal elimination halflife (t½) for SHR0534 after single dose after dose

    Measured: From time 0 to 168 hours after single dose

  4. Changes in the concentrations of blood glucose after SHR0534 is orally administered

    Measured: From baseline up to 8 hours after single dose

Timeline

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

  1. First posted22 Apr 2016 (estimated)
  2. Study startOct 2013
  3. Primary completionDec 2013

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02749097
Sponsor's protocol ID
SHR0534A001
Status last verified
Apr 2016
First submitted
19 Apr 2016
Last updated
22 Apr 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR0534 in people with Healthy, run by Jiangsu HengRui Medicine Co., Ltd..

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 11 inclusion and 21 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 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Number of treatment emergent adverse events (TEAEs) (time frame: From baseline up to 8 days after single dose). 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 NCT02749097.

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 22 Apr 2016.

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