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

NCT05906836 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18727J2G-MC-JZPB
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Drug Drug Interaction Trial; Selpercatinib (Retevmo®)

Outcome Measures

Primary Outcomes (2)

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

  PK: Cmax of Rosuvastatin was reported.

  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.

  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

Study Arms (1)

Rosuvastatin + Selpercatinib

EXPERIMENTAL

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.

Drug: Rosuvastatin; Drug: Selpercatinib

Interventions

Rosuvastatin DRUG

Administered orally.

Rosuvastatin + Selpercatinib

Selpercatinib DRUG

Administered orally.

Also known as: LY3527723, LOXO-292, Retevmo®

Rosuvastatin + Selpercatinib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Labcorp Clinical Research LP

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; selpercatinib

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08005455979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: July 27, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: September 16, 2025
• Results First Posted: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)