A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants
- Registration Number
- NCT05324124
- Lead Sponsor
- Loxo Oncology, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Selpercatinib (Fasted/Fed) Selpercatinib Period 1: 160 milligrams (mg) Selpercatinib administered orally on Day 1 in fasted state. Period 2: 160 mg Selpercatinib administered orally on Day 8 in fed state. Selpercatinib (Fed/Fasted) Selpercatinib Period 1: 160 mg Selpercatinib administered orally on Day 1 in fed state. Period 2: 160 mg Selpercatinib administered orally on Day 8 in fasted state.
- Primary Outcome Measures
Name Time Method Pharmacokinetics(PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose; PK: AUC\[0-∞\] of Selpercatinib'
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose; PK: AUC\[0-tlast\] of Selpercatinib
PK: Maximum Concentration (Cmax) of Selpercatinib PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose; PK: Cmax of Selpercatinib.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lilly Centre for Clinical Pharmacology
🇸🇬Singapore, Singapore