A Phase 1 interventional study of Selpercatinib in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
The main purpose of this study is to determine how safe and how well tolerated selpercatinib is when given as oral doses to healthy participants. The study will also assess how fast selpercatinib gets into the blood stream and how long it takes the body to remove it. The study will last up to about 6 weeks, inclusive of screening period.
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Selpercatinib administered orally.
Drug: Selpercatinib
Selpercatinib administered orally.
Drug: Selpercatinib
Selpercatinib administered orally.
Drug: Selpercatinib
Administered orally.
Also known as: LY3527723, LOXO-292
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline through Day 8
Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Selpercatinib
PK: AUC0-t of Selpercatinib
Time frame: Pre-dose up to 168 hour post-dose
PK: Area under the concentration-time curve, from time 0 to Hour 24 (AUC0-24) of Selpercatinib
PK: AUC0-24 of Selpercatinib
Time frame: Pre-dose up to 168 hour post-dose
PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib
PK: AUC0-inf of Selpercatinib
Time frame: Pre-dose up to 168 hour post-dose
PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib
PK: AUC%extrap of Selpercatinib
Time frame: Pre-dose up to 168 hour post-dose
PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Selpercatinib
PK: CL/F of Selpercatinib
Time frame: Pre-dose up to 168 hour post-dose
PK: Maximum observed concentration (Cmax) of Selpercatinib
PK: Cmax of Selpercatinib
Time frame: Pre-dose up to 168 hour post-dose
PK: Time to reach Cmax (Tmax) of Selpercatinib
PK: Tmax of Selpercatinib
Time frame: Pre-dose up to 168 hour post-dose
PK: Apparent first-order terminal elimination rate constant (Kel) of Selpercatinib
PK: Kel of Selpercatinib
Time frame: Pre-dose up to 168 hour post-dose
PK: Apparent volume of distribution during the terminal elimination phase (Vz/F) of Selpercatinib
PK: Vz/F of Selpercatinib
Time frame: Pre-dose up to 168 hour post-dose
Plan to share: No
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company