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

Loxo Oncology

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Selpercatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05324124

18178

J2G-MC-JZPA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Selpercatinib (Fasted/Fed)

Experimental group

Description:

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.

Treatment:

Drug: Selpercatinib

Selpercatinib (Fed/Fasted)

Experimental group

Description:

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.

Treatment:

Drug: Selpercatinib