A Drug Drug Interaction (DDI) Study of Selpercatinib (LY3527723) and Rosuvastatin in Healthy Participants
Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single Dose Selpercatinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Sponsor: Eli Lilly and Company
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
Time frame: Day 1 and Day 5: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours (h) post dose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Rosuvastatin
Time frame: Day 1 and Day 5: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h post dose
Eligibility Criteria
Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation * Participant must be Caucasian * Body mass index (BMI) within the range of 19.0 to 32.0 kilograms per meter squared (kg/m²) Exclusion Criteria: * Have known allergies to selpercatinib-related compounds or any components of the formulation of selpercatinib, or or rosuvastatin * • Have a significant previous or current 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 * Have used or are intending to use over-the-counter or prescription medication, including dietary supplements and herbal medications, within 14 days prior to dosing
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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