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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-19

Study Completion Date

2022-06-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Selpercatinib (Fasted/Fed)

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.

Group Type EXPERIMENTAL

Selpercatinib

Intervention Type DRUG

Administered orally.

Selpercatinib (Fed/Fasted)

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.

Group Type EXPERIMENTAL

Selpercatinib

Intervention Type DRUG

Administered orally.

Interventions

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Selpercatinib

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LY3527723 LOXO-292

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes