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NCT05324124 Clinical Trial

A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants

Healthy Clinical Trial

Official title:
An Open-Label, Randomized, Two-Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Selpercatinib in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05324124
Other study ID # 18178
Secondary ID J2G-MC-JZPA
Status Completed
Phase Phase 1
First received
Last updated
Start date April 19, 2022
Est. completion date June 22, 2022

Study information
Verified date July 2022
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to learn about how food affects selpercatinib in healthy participants. The selpercatinib will be administered in fed and fasted states. Participation could last about 7 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date June 22, 2022
Est. primary completion date June 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: - Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs and clinical laboratory tests. Exclusion Criteria: - Have a 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; or of interfering with the interpretation of data.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Selpercatinib
Administered orally.

Locations
Country Name City State
Singapore Lilly Centre for Clinical Pharmacology Singapore

Sponsors (2)
Lead Sponsor Collaborator
Loxo Oncology, Inc. Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics(PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Selpercatinib PK: AUC[0-8] of Selpercatinib Predose on day 1 until Day 4, and Predose on Day 8 until Day 11
Primary PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib PK: AUC[0-tlast] of Selpercatinib Predose on day 1 until Day 4, and Predose on Day 8 until Day 11
Primary PK: Maximum Concentration (Cmax) of Selpercatinib PK: Cmax of Selpercatinib Predose on day 1 until Day 4, and Predose on Day 8 until Day 11
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