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

Eli Lilly and Company28 enrolled

Overview

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 also evaluated 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

RosuvastatinDRUG

Administered orally.

SelpercatinibDRUG

Administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Labcorp Clinical Research LP

Dallas, Texas, United States

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin

PK: Cmax of Rosuvastatin was reported.

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

PK: AUC(0-∞) of Rosuvastatin was reported.

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

Data from ClinicalTrials.gov

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