A Drug Drug Interaction (DDI) Study of Selpercatinib (LY3527723) and Rosuvastatin in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to determine the effect of selpercatinib on the levels of rosuvastatin in the blood stream in healthy participants. This study will also evaluate the safety and tolerability of rosuvastatin when administered in combination with selpercatinib in healthy participants. This study will last up to approximately 26 days excluding screening period.

Official Title
-----------------
Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single Dose Selpercatinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Selpercatinib


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin + Selpercatinib<br>Rosuvastatin administered orally on day 1 followed by rosuvastatin administered with selpercatinib on day 5 orally. | Drug: Rosuvastatin<br>* Administered orally.<br>Drug: Selpercatinib<br>* Administered orally.<br>* Other names: Retevmo®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin | PK: Cmax of Rosuvastatin | Pre-dose up to 72 hours post-dose | 
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of Rosuvastatin | PK: AUC(0-∞) of Rosuvastatin | Pre-dose up to 72 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Drug Interaction Trial, Selpercatinib (Retevmo®)