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

Healthy Clinical Trial

Official title:

Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single Dose Selpercatinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05906836
• Other study ID #: 18727
• Secondary ID: J2G-MC-JZPB
• Status: Completed
• Phase: Phase 1
• Start date: July 27, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Rosuvastatin
Administered orally.
• Selpercatinib
Administered orally.

Locations

Country	Name	City	State
United States	Labcorp Clinical Research LP	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin	PK: Cmax of Rosuvastatin	Pre-dose up to 72 hours post-dose
Primary	PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-8]) of Rosuvastatin	PK: AUC(0-8) of Rosuvastatin	Pre-dose up to 72 hours post-dose