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 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.

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: 2025-08
• Results First Submitted: 2025-08-28
• Results First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Results First Posted: 2025-09-16
• Last Update Posted: 2025-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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	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.
Rosuvastatin + Selpercatinib	Selpercatinib	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin	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: Cmax of Rosuvastatin was reported.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Rosuvastatin	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	PK: AUC(0-∞) of Rosuvastatin was reported.

Trial Locations

Locations (1)

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