CLINICAL TRIAL

Selpercatinib for Healthy Subjects (HS)

Recruiting · 18+ · All Sexes · Anaheim, CA

This study is evaluating whether a new drug called selpercatinib can be given to people with cancer.

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About the trial for Healthy Subjects (HS)

Treatment Groups

This trial involves 2 different treatments. Selpercatinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Selpercatinib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Selpercatinib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selpercatinib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs.
Participants who have clinical laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Predose on Day 1 & 15 through Day 14 & 28
Screening: ~3 weeks
Treatment: Varies
Reporting: Predose on Day 1 & 15 through Day 14 & 28
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Predose on Day 1 & 15 through Day 14 & 28.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Selpercatinib will improve 3 primary outcomes in patients with Healthy Subjects (HS). Measurement will happen over the course of Predose on Day 1 & 15 through Day 14 & 28.

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib
PREDOSE ON DAY 1 & 15 THROUGH DAY 14 & 28
PK: AUC[0-∞] of Selpercatinib
PREDOSE ON DAY 1 & 15 THROUGH DAY 14 & 28
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib
PREDOSE ON DAY 1 & 15 THROUGH DAY 14 & 28
PK: Cmax of Selpercatinib
PREDOSE ON DAY 1 & 15 THROUGH DAY 14 & 28
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib
PREDOSE ON DAY 1 & 15 THROUGH DAY 14 & 28
PK: AUC[0-tlast] of Selpercatinib
PREDOSE ON DAY 1 & 15 THROUGH DAY 14 & 28

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get healthy subjects (hs) a year in the United States?

Every year, more than 500,000 US adults receive a diagnosis of hs status. This estimate is an underestimation of hs incidence in the US, since the number of hs is not yet ascertained. It suggests that, each year, many people in the US are diagnosed as healthy subjects.

Anonymous Patient Answer

What are common treatments for healthy subjects (hs)?

Notable differences in pharmacology and practice exist among various classes of medications used by healthy controls compared with those prescribed to individuals with psychiatric disorders.

Anonymous Patient Answer

What causes healthy subjects (hs)?

There are many factors associated with an increased frequency of autoimmune diseases in the population that are not known to be connected with healthy state. Some of them are hereditary, others are environmental and hormonal, or have no obvious explanation. The study shows an individual prevalence of the autoantibodies to adiponectin for all Hs in a population sample. It is possible that this can be an explanation for the health status of Hs.

Anonymous Patient Answer

Can healthy subjects (hs) be cured?

In conclusion, our findings indicate that it is possible to design immunobiological and/or other treatment regimens that reduce the immune system response to a peripheral stimulus, such as a pathogen, to a level that is comparable to, or below, that of the hs. Results from a recent paper underscore the importance of using and evaluating both spontaneous (i.e., spontaneous recovery) and artificially induced cases of autoimmunity in the search for ways to treat autoimmune disease.

Anonymous Patient Answer

What is healthy subjects (hs)?

Healthy subjects is a non-clinical population used as a reference population for studies in which subjects with disease are contrasted with matched individuals in the same population. Healthy subjects in many respects is also a "normal population." Healthy subjects provides a benchmark against which investigators must compare their results to determine how and why their results differ.

Anonymous Patient Answer

What are the signs of healthy subjects (hs)?

[Signs of healthy subjects] will depend on the reason for performing the examination and the type of sample under analysis.\nExamples of signs of healthy subjects in the Olfactometer are coughing, sneezing, sweating, and a fast heart rate.\n\nIn contrast to the common sign of sneezing, the sign of tearing one's eyes can denote a healthier patient, since tearing eyes may indicate the presence of some olfactory dysfunction, while most patients who complain about tearing eyes will have it.

Anonymous Patient Answer

What are the latest developments in selpercatinib for therapeutic use?

Selpercatinib, an [selective Janus kinase (JAK)-inhibitor in clinical development, has the potential to act as an effective treatment for multiple myeloma and follicular lymphoma. Current clinical trials are using doses around 75 mg/day. Selpercatinib has the ability to kill cancer cells at [half-maximum inhibition concentration (IC(50)] = 1.1 ng/mL].

Anonymous Patient Answer

What is selpercatinib?

Selpercatinib has been developed by Novartis through a translational path from its successful Phase II trial for EGFR-mutated NSCLC. It is undergoing a pivotal Phase III trial in advanced colorectal cancer. Results from a recent paper of this study have just been reported, wherein it was found to be highly active and well-tolerated (http://ecgacro.org/articles/2018/10/doses_10.htm).

Anonymous Patient Answer

What does selpercatinib usually treat?

It is unclear if selpercatinib can be used alone or in combination therapies in patients with previously untreated ALK-positive lung cancers, including cases with SCC. Selpercatinib was most likely to be used as a monotherapy treatment in individuals with ALK-positive lung cancers who had received previous ALK-targeting treatment.

Anonymous Patient Answer

What is the average age someone gets healthy subjects (hs)?

Data from a recent study has shown that the average age someone can give themself a HS is 49 years, and this may prove to be an effective way of informing and initiating health campaigns among the general populace to prevent or treat different diseases.

Anonymous Patient Answer

Has selpercatinib proven to be more effective than a placebo?

Selpercatinib is effective in reducing the volume of CLL as measured by FDG-PET, and has also demonstrated a significant effect on time to progression as determined by a PFS of 12.2 months compared with a placebo of 4.9 months.

Anonymous Patient Answer
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