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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rosuvastatin; Drug: Selpercatinib

• Registration Number: NCT05906836
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-18
• Study Start: 2023-07-27
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin + Selpercatinib	Rosuvastatin	Rosuvastatin administered orally on day 1 followed by rosuvastatin administered with selpercatinib on day 5 orally.
Rosuvastatin + Selpercatinib	Selpercatinib	Rosuvastatin administered orally on day 1 followed by rosuvastatin administered with selpercatinib on day 5 orally.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Labcorp Clinical Research LP; 🇺🇸 Dallas, Texas, United States