HealthyPhase 1NCT05468164

A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants

A Phase 1 study testing Selpercatinib and Omeprazole in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Selpercatinib and Omeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 31 May 2018to 13 Sep 2018
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Non-vasectomized, male participants must have agreed to use a condom with spermicide or abstain from sexual intercourse during the study until 6 months after the last dosing. (No restrictions were required for a vasectomized male provided his vasectomy had been performed 4 months or more prior to the first dosing of study drug)
If male, must have agreed not to donate sperm from the first dosing until 6 months after the last dosing
Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Who cannot join

Had a history of gastritis, gastrointestinal tract or hepatic disorder or other clinical condition that might have, in the opinion of the Principal Investigator or designee, and as confirmed by the Sponsor, affected the absorption, distribution, biotransformation, or excretion of LOXO 292 or omeprazole

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: An Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Single-Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects

The main purpose of this study is to assess the effect of food on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it after a high-fat meal, and the effect of a change in gastric pH after multiple doses of omeprazole on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it when administered under fasted and fed conditions in healthy participants. The study will also evaluate the safety and tolerability of selpercatinib in healthy participants. The study will last up to 33 days excluding the screening period.

Conditions: Healthy
Being tested: Selpercatinib, Omeprazole

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
OmeprazoleDrug
Administered orally

Study groups in NCT05468164
Study group	Role	What they receive
Treatment Sequence 1: ABCD	Experimental	Participants received: * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fasted state. * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fed state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fasted state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fed state. Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. Receives: Drug: Selpercatinib; Drug: Omeprazole
Treatment Sequence 2: ABDC	Experimental	Participants received: * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fasted state. * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fed state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fed state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fasted state. Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. Receives: Drug: Selpercatinib; Drug: Omeprazole
Treatment Sequence 3: BACD	Experimental	Participants received: * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fed state. * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fasted state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fasted state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fed state. Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. Receives: Drug: Selpercatinib; Drug: Omeprazole
Treatment Sequence 4: BADC	Experimental	Participants received: * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fed state. * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fasted state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fed state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fasted state. Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. Receives: Drug: Selpercatinib; Drug: Omeprazole

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib
PK: AUC0-t of Selpercatinib was reported.
Measured: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: Area Under the Concentration-time Curve, From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib
PK: AUC0-inf of Selpercatinib was reported.
Measured: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib
PK: AUC%extrap of Selpercatinib was reported.
Measured: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: Maximum Observed Concentration (Cmax) of Selpercatinib
PK: Cmax of Selpercatinib was reported.
Measured: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: Time to Reach Cmax (Tmax) of Selpercatinib
PK: Tmax of Selpercatinib was reported.
Measured: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib
PK: Kel of Selpercatinib was reported.
Measured: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib
PK: CL/F of Selpercatinib was reported.
Measured: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib
PK: t½ of Selpercatinib was reported.
Measured: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.

Timeline

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

31 May 201813 Sep 2018

First posted21 Jul 2022
Study start31 May 2018
Primary completion13 Sep 2018
Study completion13 Sep 2018

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.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05468164
Sponsor's protocol ID: 17752
Other IDs: J2G-MC-JZJQ, LOXO-RET-18015
Status last verified: Aug 2025
First submitted: 19 Jul 2022
Last updated: 19 Sep 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Single-Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT05468164
Acronym / sponsor ID: 17752
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Loxo Oncology, Inc.
Study start: 31 May 2018 (actual)
Primary completion: 13 Sep 2018 (actual)
Study completion: 13 Sep 2018 (actual)
First posted: 21 Jul 2022 (actual)
Results: Posted 19 Sep 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: 4

Arm	Type	Receives
Treatment Sequence 1: ABCD	Experimental	Drug: Selpercatinib, Drug: OmeprazoleParticipants received: * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fasted state. * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fed state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fasted state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fed state. Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.
Treatment Sequence 2: ABDC	Experimental	Drug: Selpercatinib, Drug: OmeprazoleParticipants received: * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fasted state. * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fed state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fed state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fasted state. Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.
Treatment Sequence 3: BACD	Experimental	Drug: Selpercatinib, Drug: OmeprazoleParticipants received: * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fed state. * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fasted state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fasted state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fed state. Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.
Treatment Sequence 4: BADC	Experimental	Drug: Selpercatinib, Drug: OmeprazoleParticipants received: * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fed state. * Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fasted state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fed state. * Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fasted state. Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Non-vasectomized, male participants must have agreed to use a condom with spermicide or abstain from sexual intercourse during the study until 6 months after the last dosing. (No restrictions were required for a vasectomized male provided his vasectomy had been performed 4 months or more prior to the first dosing of study drug)
If male, must have agreed not to donate sperm from the first dosing until 6 months after the last dosing
Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Key exclusion criteria (1 listed)

Had a history of gastritis, gastrointestinal tract or hepatic disorder or other clinical condition that might have, in the opinion of the Principal Investigator or designee, and as confirmed by the Sponsor, affected the absorption, distribution, biotransformation, or excretion of LOXO 292 or omeprazole

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	Treatment Sequence 1: ABCD, Treatment Sequence 2: ABDC, Treatment Sequence 3: BACD, Treatment Sequence 4: BADC
OmeprazoleAdministered orally	Drug	Treatment Sequence 1: ABCD, Treatment Sequence 2: ABDC, Treatment Sequence 3: BACD, Treatment Sequence 4: BADC

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: AUC0-t of Selpercatinib was reported.
PK: Area Under the Concentration-time Curve, From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: AUC0-inf of Selpercatinib was reported.
PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: AUC%extrap of Selpercatinib was reported.
PK: Maximum Observed Concentration (Cmax) of Selpercatinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: Cmax of Selpercatinib was reported.
PK: Time to Reach Cmax (Tmax) of Selpercatinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: Tmax of Selpercatinib was reported.
PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: Kel of Selpercatinib was reported.
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: CL/F of Selpercatinib was reported.
PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.
PK: t½ of Selpercatinib was reported.

Results and safety

Results posted to the registry on 19 Sep 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
Treatment Sequence 1: ABCD	5	5
Treatment Sequence 2: ABDC	5	5
Treatment Sequence 3: BACD	5	5
Treatment Sequence 3: BADC	5	5

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib

Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*h/mL)

Measure	Treatment A: 160 mg Selpercatinib (Fasted) n = 20	Treatment B: 160 mg Selpercatinib (Fed) n = 20	Treatment C: 160 mg Selpercatinib + 40 mg Omeprazole (Fasted) n = 19	Treatment D: 160 mg Selpercatinib + 40 mg Omeprazole (Fed) n = 20
Value	26160 (38.9)	28400 (20.4)	7973 (161.9)	26570 (14.1)

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

Primary outcome: PK: Area Under the Concentration-time Curve, From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib

Measure	Treatment A: 160 mg Selpercatinib (Fasted) n = 20	Treatment B: 160 mg Selpercatinib (Fed) n = 20	Treatment C: 160 mg Selpercatinib + 40 mg Omeprazole (Fasted) n = 19	Treatment D: 160 mg Selpercatinib + 40 mg Omeprazole (Fed) n = 20
Value	26280 (38.9)	28530 (20.4)	8256 (143.3)	26770 (13.8)

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

Primary outcome: PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib

Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.. Mean (Standard Deviation). Unit: percentage of AUC0-inf extrapolated

Measure	Treatment A: 160 mg Selpercatinib (Fasted) n = 20	Treatment B: 160 mg Selpercatinib (Fed) n = 20	Treatment C: 160 mg Selpercatinib + 40 mg Omeprazole (Fasted) n = 19	Treatment D: 160 mg Selpercatinib + 40 mg Omeprazole (Fed) n = 20
Value	0.4468 (0.14909)	0.4541 (0.22000)	3.065 (7.5841)	0.7158 (0.46382)

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

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

Measure	Treatment A: 160 mg Selpercatinib (Fasted) n = 20	Treatment B: 160 mg Selpercatinib (Fed) n = 20	Treatment C: 160 mg Selpercatinib + 40 mg Omeprazole (Fasted) n = 19	Treatment D: 160 mg Selpercatinib + 40 mg Omeprazole (Fed) n = 20
Value	2024 (60.4)	1745 (20.9)	251.5 (263.9)	1023 (24.7)

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

Adverse events

Time frame: Baseline to End of Follow-up (Up To 39 Days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: 160 mg Selpercatinib (Fasted)	0 of 20 (0%)	3 of 20 (15%)	0 of 20
Treatment B: 160 mg Selpercatinib (Fed)	0 of 20 (0%)	6 of 20 (30%)	0 of 20
Treatment C: 160 mg Selpercatinib + 40 mg Omeprazole (Fasted)	0 of 19 (0%)	7 of 19 (36.8%)	0 of 19
Treatment D: 160 mg Selpercatinib + 40 mg Omeprazole (Fed)	0 of 20 (0%)	8 of 20 (40%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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 and Omeprazole in people with Healthy, run by Eli Lilly and Company at 1 site 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 5 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 19 Sep 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 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 19 Sep 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 Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib (time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4.). The study lists 8 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 NCT05468164.

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 19 Sep 2025.