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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Selpercatinib; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05906836

18727

J2G-MC-JZPB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Rosuvastatin + Selpercatinib

Experimental group

Description:

Participants received 20 milligram (mg) of rosuvastatin administered orally on Day 1, followed by 20 mg of rosuvastatin coadministered orally with 160 mg of selpercatinib on Day 5.

Treatment:

Drug: Rosuvastatin

Drug: Selpercatinib