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Selpercatinib for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Loxo Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 1 & 15 through day 14 & 28
Awards & highlights

Study Summary

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 & 15 through day 14 & 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 & 15 through day 14 & 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Selpercatinib (Test)Experimental Treatment1 Intervention
Selpercatinib given orally on days 1 and 15.
Group II: Selpercatinib (Reference)Active Control1 Intervention
Selpercatinib given orally on days 1 and 15.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selpercatinib
2021
Completed Phase 1
~600

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Loxo Oncology, Inc.Lead Sponsor
65 Previous Clinical Trials
9,785 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,603 Previous Clinical Trials
3,199,406 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,336 Previous Clinical Trials
403,581 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Texas
California
How old are they?
18 - 65
What site did they apply to?
Anaheim Clinical Trials, LLC
Covance Dallas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~67 spots leftby Mar 2025