HealthyPhase 1NCT05338489

A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants

A Phase 1 study testing Selpercatinib, Itraconazole and Rifampin 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

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Trial summary

The main purpose of this study is to assess the effect of itraconazole and rifampin on how fast selpercatinib gets into the blood stream and how long it takes the body to remove it when administered in healthy participants. Information about safety and tolerability will be collected. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Selpercatinib, Itraconazole and Rifampin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 11 May 2018to 22 Aug 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

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

Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
Have previously participated or withdrawn from this study
Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2

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: A 2-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects

Conditions: Healthy
Being tested: Selpercatinib, Itraconazole, Rifampin

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.
ItraconazoleDrug
Administered orally.
RifampinDrug
Administered orally.

Study groups in NCT05338489
Study group	Role	What they receive
Part 1 - 160 mg Selpercatinib + 200 mg Itraconazole	Experimental	Participants received a single oral dose of 160 milligrams (mg) selpercatinib on Day 1 of Period 1. In Period 2, participants received an oral dose of 200 mg itraconazole administered once daily (QD) for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2. There was a washout period of at least 7 days between the dose of selpercatinib in Period 1 and the first dose of itraconazole in Period 2. Receives: Drug: Selpercatinib; Drug: Itraconazole
Part 2 - 160 mg Selpercatinib + 600 mg Rifampin	Experimental	Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1. In Period 2, participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 and Day 10 of Period 2. There was a washout period of at least 7 days between the dose of selpercatinib in Period 1 and the first dose of rifampin and selpercatinib in Period 2. Receives: Drug: Selpercatinib; Drug: Rifampin

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.
Outcome measure timeframe:
Parts 1 and 2, Period 1: (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.
Part 1, Period 2; (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. (contd.)
Measured: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib
PK: AUC0-inf of Selpercatinib was reported.
Outcome measure timeframe:
Parts 1 and 2, Period 1: (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.
Part 1, Period 2; (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. (contd.)
Measured: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: Percentage of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib
PK: AUC%extrap of Selpercatinib was reported.
Outcome measure timeframe:
Parts 1 and 2, Period 1: (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.
Part 1, Period 2; (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. (contd.)
Measured: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: Maximum Observed Concentration (Cmax) of Selpercatinib
PK: Maximum observed concentration (Cmax) of Selpercatinib was reported.
Outcome measure timeframe:
Parts 1 and 2, Period 1: (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.
Part 1, Period 2; (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.
Measured: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: Time to Reach Cmax (Tmax) of Selpercatinib
PK: Tmax of Selpercatinib was reported.
Outcome measure timeframe:
Parts 1 and 2, Period 1: (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.
Part 1, Period 2; (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. (contd.)
Measured: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: Apparent First-order Terminal Elimination Rate Constant (Kel) of Selpercatinib
PK: Kel of Selpercatinib was reported.
Outcome measure timeframe:
Parts 1 and 2, Period 1: (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.
Part 1, Period 2; (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. (contd.)
Measured: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib
PK: CL/F of Selpercatinib was reported.
Outcome measure timeframe:
Parts 1 and 2, Period 1: (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.
Part 1, Period 2; (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. (contd.)
Measured: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib
PK: t½ of Selpercatinib was reported.
Outcome measure timeframe:
Parts 1 and 2, Period 1: (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.
Part 1, Period 2; (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. (contd.)
Measured: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
Part 2 - PK: Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Selpercatinib Post Dose Day 1
PK: AUC0-24 of Selpercatinib in Part 2 was reported.
Measured: Part 2, Periods 1 and 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose.

Timeline

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

11 May 201822 Aug 2018

First posted21 Apr 2022
Study start11 May 2018
Primary completion28 Jul 2018
Study completion22 Aug 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05338489
Sponsor's protocol ID: 17751
Other IDs: J2G-OX-JZJP, LOXO-RET-18014
Status last verified: Aug 2025
First submitted: 19 Apr 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?

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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: A 2-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT05338489
Acronym / sponsor ID: 17751
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Loxo Oncology, Inc.
Study start: 11 May 2018 (actual)
Primary completion: 28 Jul 2018 (actual)
Study completion: 22 Aug 2018 (actual)
First posted: 21 Apr 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Part 1 - 160 mg Selpercatinib + 200 mg Itraconazole	Experimental	Drug: Selpercatinib, Drug: ItraconazoleParticipants received a single oral dose of 160 milligrams (mg) selpercatinib on Day 1 of Period 1. In Period 2, participants received an oral dose of 200 mg itraconazole administered once daily (QD) for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2. There was a washout period of at least 7 days between the dose of selpercatinib in Period 1 and the first dose of itraconazole in Period 2.
Part 2 - 160 mg Selpercatinib + 600 mg Rifampin	Experimental	Drug: Selpercatinib, Drug: RifampinParticipants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1. In Period 2, participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 and Day 10 of Period 2. There was a washout period of at least 7 days between the dose of selpercatinib in Period 1 and the first dose of rifampin and selpercatinib in Period 2.

Who may qualify

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

Key inclusion criteria (3 listed)

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 (5 listed)

Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
Have previously participated or withdrawn from this study
Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2

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	Part 1 - 160 mg Selpercatinib + 200 mg Itraconazole, Part 2 - 160 mg Selpercatinib + 600 mg Rifampin
ItraconazoleAdministered orally.	Drug	Part 1 - 160 mg Selpercatinib + 200 mg Itraconazole
RifampinAdministered orally.	Drug	Part 2 - 160 mg Selpercatinib + 600 mg Rifampin

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: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: AUC0-t of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (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. Part 1, Period 2; (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. (contd.)
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib
Time frame: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: AUC0-inf of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (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. Part 1, Period 2; (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. (contd.)
PK: Percentage of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib
Time frame: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: AUC%extrap of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (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. Part 1, Period 2; (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. (contd.)
PK: Maximum Observed Concentration (Cmax) of Selpercatinib
Time frame: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: Maximum observed concentration (Cmax) of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (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. Part 1, Period 2; (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.
PK: Time to Reach Cmax (Tmax) of Selpercatinib
Time frame: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: Tmax of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (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. Part 1, Period 2; (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. (contd.)
PK: Apparent First-order Terminal Elimination Rate Constant (Kel) of Selpercatinib
Time frame: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: Kel of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (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. Part 1, Period 2; (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. (contd.)
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib
Time frame: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: CL/F of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (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. Part 1, Period 2; (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. (contd.)
PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib
Time frame: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.
PK: t½ of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (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. Part 1, Period 2; (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. (contd.)
Part 2 - PK: Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Selpercatinib Post Dose Day 1
Time frame: Part 2, Periods 1 and 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose.
PK: AUC0-24 of Selpercatinib in Part 2 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
Part 1 - 160 mg Selpercatinib + 200 mg Itraconazole	12	12
Part 2 - 160 mg Selpercatinib + 600 mg Rifampin	12	12

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: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram *hour per milliliter (ng*h/mL)

Measure	Part 1 Period 1: 160 mg Selpercatinib n = 12	Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole n = 12	Part 2 Period 1: 160 mg Selpercatinib n = 12	Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin n = 12	Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin n = 12
Value	22380 (31.8)	51570 (41.9)	21070 (24.4)	14080 (39.2)	2784 (39.1)

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

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

Measure	Part 1 Period 1: 160 mg Selpercatinib n = 12	Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole n = 12	Part 2 Period 1: 160 mg Selpercatinib n = 12	Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin n = 12	Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin n = 12
Value	22490 (31.4)	52450 (41.6)	21180 (23.9)	16310 (33.4)	2820 (38.9)

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

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

Measure	Part 1 Period 1: 160 mg Selpercatinib n = 12	Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole n = 12	Part 2 Period 1: 160 mg Selpercatinib n = 12	Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin n = 12	Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin n = 12
Value	0.3377 (82.1)	1.531 (48.1)	0.3405 (98.9)	12.33 (44.7)	1.081 (67.9)

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

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

Measure	Part 1 Period 1: 160 mg Selpercatinib n = 12	Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole n = 12	Part 2 Period 1: 160 mg Selpercatinib n = 12	Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin n = 12	Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin n = 12
Value	1442 (79.7)	1880 (78.0)	1364 (49.6)	1624 (52.6)	411.2 (40.3)

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

Adverse events

Time frame: Baseline Up To 50 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 Period 1: 160 mg Selpercatinib	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Part 2 Period 1: 160 mg Selpercatinib	0 of 12 (0%)	3 of 12 (25%)	0 of 12
Part 2 Period 2: 160 mg Selpercatinib + 600 mg Rifampin	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12

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

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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

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, Itraconazole and Rifampin 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 3 inclusion and 5 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: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) 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.). The study lists 9 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 NCT05338489.

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; AzTrials last refreshed its copy on 8 Nov 2026.