HealthyPhase 1NCT05089019

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

A Phase 1 study testing Selpercatinib in people with Healthy, run by Loxo Oncology, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Selpercatinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 224 participants
Where: 4 sitesUnited States
Study dates: 29 Oct 2021to 19 Jul 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Covance Dallas
Dallas, Texas, 75247
LabCorp CRU, Inc.
Daytona Beach, Florida, 32117
LabCorp CRU, Inc.
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: An Open-Label, Randomized Study to Evaluate the Bioequivalence of Selpercatinib Formulations

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.

Conditions: Healthy
Being tested: Selpercatinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SelpercatinibDrug
Also called LY3527723, LOXO-292
Administered orally

Study groups in NCT05089019
Study group	Role	What they receive
Selpercatinib (Test)	Experimental	160 mg Selpercatinib (tablet formulation) given orally on days 1 and 15. Receives: Drug: Selpercatinib
Selpercatinib (Reference)	Active comparator	160 mg Selpercatinib (2 X 80 mg capsule formulation) given orally on days 1 and 15. Receives: Drug: Selpercatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib
PK: Cmax of Selpercatinib
Measured: 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: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib
PK: AUC[0-∞] of Selpercatinib.
Measured: 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;
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib
PK: AUC[0-tlast] of Selpercatinib
Measured: 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;

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 202119 Jul 2022

First posted22 Oct 2021
Study start29 Oct 2021
Primary completion19 Jul 2022
Study completion19 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05089019
Sponsor's protocol ID: 18177
Other IDs: J2G-MC-JZJZ
Status last verified: Feb 2025
First submitted: 21 Oct 2021
Last updated: 17 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized Study to Evaluate the Bioequivalence of Selpercatinib Formulations
ClinicalTrials.gov ID: NCT05089019
Acronym / sponsor ID: 18177
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: Loxo Oncology, Inc.Industry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 29 Oct 2021 (actual)
Primary completion: 19 Jul 2022 (actual)
Study completion: 19 Jul 2022 (actual)
First posted: 22 Oct 2021 (actual)
Results: Posted 17 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Selpercatinib (Test)	Experimental	Drug: Selpercatinib160 mg Selpercatinib (tablet formulation) given orally on days 1 and 15.
Selpercatinib (Reference)	Active comparator	Drug: Selpercatinib160 mg Selpercatinib (2 X 80 mg capsule formulation) given orally on days 1 and 15.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SelpercatinibAlso: LY3527723, LOXO-292Administered orally	Drug	Selpercatinib (Reference), Selpercatinib (Test)

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib
Time frame: 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
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib
Time frame: 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.
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib
Time frame: 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

Results and safety

Results posted to the registry on 17 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 - Selpercatinib Reference/Test	112	112
Sequence 2 - Selpercatinib Test/Reference	112	111

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib

Time frame: 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;. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	160 mg Selpercatinib (Reference) n = 209	160 mg Selpercatinib (Test) n = 206
Value	1520 (61)	1350 (91)

160 mg Selpercatinib (Reference) vs 160 mg Selpercatinib (Test): Ratio of Geometric LS Mean: 0.889 (94.12% CI 0.810 to 0.976), Mixed Models Analysis

Population analysed: All participants who received at least 1 dose of Selpercatinib and have evaluable PK data.

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

Measure	160 mg Selpercatinib (Reference) n = 206	160 mg Selpercatinib (Test) n = 200
Value	20700 (45)	19300 (51)

160 mg Selpercatinib (Reference) vs 160 mg Selpercatinib (Test): Ratio of Geometric LS Mean: 0.927 (94.12% CI 0.882 to 0.975), Mixed Models Analysis

Population analysed: All participants who received at least one dose of selpercatinib and had evaluable PK data.

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

Measure	160 mg Selpercatinib (Reference) n = 206	160 mg Selpercatinib (Testt) n = 204
Value	20200 (47)	18100 (65)

160 mg Selpercatinib (Reference) vs 160 mg Selpercatinib (Testt): Ratio of Geometric LS Mean: 0.891 (94.12% CI 0.834 to 0.951), Mixed Models Analysis

Population analysed: All participants who received at least one dose of selpercatinib and had evaluable PK data.

Adverse events

Time frame: Baseline up to 28 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
160 mg Selpercatinib (2 x 80 mg Reference)	0 of 216 (0%)	0 of 216 (0%)	0 of 216
160 mg Selpercatinib (1 x 160 mg Test)	0 of 212 (0%)	0 of 212 (0%)	0 of 212

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Selpercatinib in people with Healthy, run by Loxo Oncology, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib (time frame: 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;). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05089019.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.