HealthyPhase 1NCT05324124

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

A Phase 1 study testing Selpercatinib in people with Healthy, run by Loxo Oncology, Inc. at 1 site in Singapore.

Completed

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

Trial summary

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. Read more about this study

Who is it for?: Ages 21 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: 46 participants
Where: 1 siteSingapore
Study dates: 19 Apr 2022to 22 Jun 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 21 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, vital signs and clinical laboratory tests.

Who cannot join

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 locations and contacts

1 site in 1 country.

Singapore1 site

Lilly Centre for Clinical Pharmacology
Singapore, 138623

Other trials in Singapore

About this study

Official title: An Open-Label, Randomized, Two-Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Selpercatinib in Healthy Participants

Conditions: Healthy
Being tested: Selpercatinib
Keywords: Selpercatinib, Food, Pharmacokinetics

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 NCT05324124
Study group	Role	What they receive
Selpercatinib (Fasted/Fed)	Experimental	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. Receives: Drug: Selpercatinib
Selpercatinib (Fed/Fasted)	Experimental	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. Receives: Drug: Selpercatinib

What is being measured

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

Pharmacokinetics(PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib
PK: AUC[0-∞] of Selpercatinib'
Measured: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;
PK: 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: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;
PK: Maximum Concentration (Cmax) of Selpercatinib
PK: Cmax of Selpercatinib.
Measured: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;

Timeline

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

19 Apr 202222 Jun 2022

First posted12 Apr 2022
Study start19 Apr 2022
Primary completion22 Jun 2022
Study completion22 Jun 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: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05324124
Sponsor's protocol ID: 18178
Other IDs: J2G-MC-JZPA
Status last verified: Feb 2025
First submitted: 5 Apr 2022
Last updated: 21 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?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Two-Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Selpercatinib in Healthy Participants
ClinicalTrials.gov ID: NCT05324124
Acronym / sponsor ID: 18178
Conditions: Healthy
Keywords: Selpercatinib, Food, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Loxo Oncology, Inc.Industry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 19 Apr 2022 (actual)
Primary completion: 22 Jun 2022 (actual)
Study completion: 22 Jun 2022 (actual)
First posted: 12 Apr 2022 (actual)
Results: Posted 21 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 (Fasted/Fed)	Experimental	Drug: SelpercatinibPeriod 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.
Selpercatinib (Fed/Fasted)	Experimental	Drug: SelpercatinibPeriod 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.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs and clinical laboratory tests.

Key exclusion criteria (1 listed)

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.

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 (Fasted/Fed), Selpercatinib (Fed/Fasted)

Primary outcome

Pharmacokinetics(PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib
Time frame: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;
PK: AUC[0-∞] of Selpercatinib'
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib
Time frame: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;
PK: AUC[0-tlast] of Selpercatinib
PK: Maximum Concentration (Cmax) of Selpercatinib
Time frame: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;
PK: Cmax of Selpercatinib.

Results and safety

Results posted to the registry on 21 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
Selpercatinib Fasted/Fed	23	22
Selpercatinib Fed/Fasted	23	22

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

Time frame: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram * hour per milliliter (ng*hr/mL

Measure	Selpercatinib Fasted (Reference) n = 44	Selpercatinib Fed (Test) n = 44
Value	23400 (32)	22500 (44)

Selpercatinib Fasted (Reference) vs Selpercatinib Fed (Test): Ratio of Geometric Least Squares Mean: 0.952 (90% CI 0.876 to 1.03)

Population analysed: All participants who received doses of study drug on Day 1 and Day 8 and had evaluable PK data.

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

Time frame: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Selpercatinib Fasted (Reference) n = 44	Selpercatinib Fed (Test) n = 44
Value	22700 (32)	21700 (46)

Selpercatinib Fasted (Reference) vs Selpercatinib Fed (Test): Ratio of Geometric Least Squares Mean: 0.949 (90% CI 0.869 to 1.04)

Population analysed: All participants who received doses of study drug on Day 1 and Day 8 and had evaluable PK data.

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

Measure	Selpercatinib Fasted (Reference) n = 44	Selpercatinib Fed (Test) n = 44
Value	1840 (39)	1540 (45)

Selpercatinib Fasted (Reference) vs Selpercatinib Fed (Test): Ratio of Geometric Least Squares Mean: 0.829 (90% CI 0.744 to 0.925)

Population analysed: All participants who received doses of study drug on Day 1 and Day 8 and had evaluable PK data.

Adverse events

Time frame: Screening up to 21 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
160 mg Selpercatinib Fasted	0 of 45 (0%)	29 of 45 (64.4%)	0 of 45
160 mg Selpercatinib Fed	0 of 45 (0%)	21 of 45 (46.7%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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

1 site 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 1 site in Singapore.

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 1 inclusion and 1 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 21 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 1 site in Singapore. 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 21 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): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib (time frame: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 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 NCT05324124.

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 21 Mar 2025.