Phase 1
Completed N=46
A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT05324124 ↗
Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Pharmacokinetics(PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib — 23400; 22500 nanogram * hour per milliliter (ng*hr/mL
Summary
The main purpose of this study is to learn about how food affects selpercatinib in healthy participants. The selpercatinib will be administered in fed and fasted states. Participation could last about 7 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics(PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib |
23400; 22500 | — |
| PRIMARY PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib |
22700; 21700 | — |
| PRIMARY PK: Maximum Concentration (Cmax) of Selpercatinib |
1840; 1540 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs and clinical laboratory tests.
Exclusion Criteria
- Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
Data sourced from ClinicalTrials.gov (NCT05324124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.