A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants

NCT05089019
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Phase
Phase 1
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Recruitment status
Completed
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Participants
224
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Lead sponsor
Loxo Oncology, Inc.
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Start date
2021-10-29
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Number of sites
4
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Summary
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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Short title
A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants
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Official title
An Open-Label, Randomized Study to Evaluate the Bioequivalence of Selpercatinib Formulations
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Control arm
Active comparator
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2022-07-19
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First posted
2021-10-22
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Registry last updated
2025-03-17
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Primary completion date
2022-07-19
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Start date
2021-10-29
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Actual participants
224
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Participants
224
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
4
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Loxo Oncology, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05089019
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ClinicalTrials.gov ID
NCT05089019
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Registry record
Open registry record
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Allocation
Randomised
Model
Crossover
Purpose
Basic science
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib

    Timeframe: Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 hours (h) postdose;

    PK: Cmax of Selpercatinib

  2. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib

    Timeframe: Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 hours (h) postdose;

    PK: AUC\[0-∞\] of Selpercatinib.

  3. Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib

    Timeframe: Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 hours (h) postdose;

    PK: AUC\[0-tlast\] of Selpercatinib

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

  • 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.

  • 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)
Sources for eligibility
clinicaltrials.gov

  • Anaheim Clinical Trials, LLCAnaheim, United States
  • LabCorp CRU, Inc.Daytona Beach, United States
  • Covance DallasDallas, United States
  • LabCorp CRU, Inc.Madison, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • J2G-MC-JZJZ
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Targets (3)