A Study Comparing Two Formulations of 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

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-29

Study Completion Date

2022-07-19

Brief Summary

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The main purpose of this study is to compare the amount of selpercatinib that gets into the blood stream and how long it takes the body to get rid of it, when given as different formulations. The information about any adverse effects experienced will be collected and the tolerability of selpercatinib will also be evaluated. The study may last up to 56 days including the 28 days of screening period.

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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 (Test)

160 mg Selpercatinib (tablet formulation) given orally on days 1 and 15.

Group Type EXPERIMENTAL

Selpercatinib

Intervention Type DRUG

Administered orally

Selpercatinib (Reference)

160 mg Selpercatinib (2 X 80 mg capsule formulation) given orally on days 1 and 15.

Group Type ACTIVE_COMPARATOR

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, and vital signs.
* Participants who have clinical laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.

Exclusion Criteria

* Have a history of allergic reactions to medications or food products
* Have a clinically significant abnormality of blood pressure and/or pulse rate as determined by the investigator
* Clinically significant abnormalities on ECG as determined by the investigator or prolongation of the QTcB or QTcF \>450 msec at screening
* Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to the planned start of selpercatinib
* 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. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
* Use of H2 blockers, proton pump inhibitors, and other drugs that affect selpercatinib exposure within 7 days of screening
* Are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen (≤2 g/24 hours), hormonal contraception, or hormone replacement therapy)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes