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A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 1 & 15 through day 14 & 28
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing selpercatinib, a medication, to see how well it gets into the bloodstream and how long it stays in the body when given in different forms. The study will also look at any side effects and how well people tolerate the medication. It aims to optimize the use of selpercatinib for patients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose on day 1 & 15 through day 14 & 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 & 15 through day 14 & 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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?
Eli Lilly and CompanyIndustry Sponsor
2,680 Previous Clinical Trials
3,466,160 Total Patients Enrolled
Loxo Oncology, Inc.Lead Sponsor
71 Previous Clinical Trials
10,836 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,617 Total Patients Enrolled