HealthyPhase 1NCT06258174

A Study of Two Different Formulations of Pirtobrutinib (LOXO-305) In Healthy Participants

A Phase 1 study testing Pirtobrutinib 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.

Trial summary

The main purpose of this study is to compare two different formulations (mixtures) of pirtobrutinib (LOXO-305) in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. 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?: Pirtobrutinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 28 Sep 2021to 22 Dec 2021
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

Males and females of non-childbearing potential.
Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).

Who cannot join

History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
liver disease
pancreatitis
peptic ulcer disease
intestinal malabsorption
cholecystectomy

Show all 17Show fewer

gastric reduction surgery
history or presence of clinically significant cardiovascular disease.
Participants with out-of-range, at-rest vital signs.
Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to Day 1.
Use or intention to use any prescription or over-the-counter medications within 14 days prior to Day 1 and through end of trial.
History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
Receipt of blood products within 2 months prior to Check-in (Day -1).
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).

Trial locations and contacts

1 site in 1 country.

United States1 site

Labcorp Drug Development
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: A Phase I, Open-Label, Randomized, 2-Way Crossover Study to Compare the PK of Pirtobrutinib (LOXO-305) Tablets

Conditions: Healthy
Being tested: Pirtobrutinib

What participants receive

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

PirtobrutinibDrug
Also called LOXO-305, LY3527727
Administered orally.

Study groups in NCT06258174
Study group	Role	What they receive
200 mg Pirtobrutinib (Sequence R/T)	Experimental	Period 1: Participants received a reference formulation (R) of oral pirtobrutinib 200 milligrams (mg) on day 1. Period 2: Participants received a test formulation (T) of oral pirtobrutinib 200 mg on day 8. There was a washout period of 7 days between the doses of pirtobrutinib. Receives: Drug: Pirtobrutinib
200 mg Pirtobrutinib (Sequence T/R)	Experimental	Period 1: Participants received a test formulation (T) of oral pirtobrutinib 200 mg on day 1. Period 2: Participants received a reference formulation (R) of oral pirtobrutinib 200 mg on day 8. There was a washout period of 7 days between the doses of pirtobrutinib. Receives: Drug: Pirtobrutinib

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib
PK: AUC0-24 of Pirtobrutinib
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib
PK: AUC0-t of Pirtobrutinib
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib
PK: AUC0-inf of Pirtobrutinib
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib
PK: %AUCextrap of Pirtobrutinib
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib
PK: CL/F of Pirtobrutinib
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib
PK: t1/2 of Pirtobrutinib
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib
PK: Cmax of Pirtobrutinib
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib
PK: Tmax of Pirtobrutinib
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib
PK: λZ of Pirtobrutinib
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Pirtobrutinib
PK: Vz/F of Pirtobrutinib
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose

Timeline

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

28 Sep 202122 Dec 2021

First posted14 Feb 2024
Study start28 Sep 2021
Primary completion22 Dec 2021
Study completion22 Dec 2021

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: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06258174
Sponsor's protocol ID: LOXO-BTK-21050
Other IDs: J2N-OX-JZNV
Status last verified: Nov 2024
First submitted: 6 Feb 2024
Last updated: 13 Jan 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-Label, Randomized, 2-Way Crossover Study to Compare the PK of Pirtobrutinib (LOXO-305) Tablets
ClinicalTrials.gov ID: NCT06258174
Acronym / sponsor ID: LOXO-BTK-21050
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Loxo Oncology, Inc.
Study start: 28 Sep 2021 (actual)
Primary completion: 22 Dec 2021 (actual)
Study completion: 22 Dec 2021 (actual)
First posted: 14 Feb 2024 (actual)
Results: Posted 13 Jan 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
200 mg Pirtobrutinib (Sequence R/T)	Experimental	Drug: PirtobrutinibPeriod 1: Participants received a reference formulation (R) of oral pirtobrutinib 200 milligrams (mg) on day 1. Period 2: Participants received a test formulation (T) of oral pirtobrutinib 200 mg on day 8. There was a washout period of 7 days between the doses of pirtobrutinib.
200 mg Pirtobrutinib (Sequence T/R)	Experimental	Drug: PirtobrutinibPeriod 1: Participants received a test formulation (T) of oral pirtobrutinib 200 mg on day 1. Period 2: Participants received a reference formulation (R) of oral pirtobrutinib 200 mg on day 8. There was a washout period of 7 days between the doses of pirtobrutinib.

Who may qualify

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

Key inclusion criteria (3 listed)

Males and females of non-childbearing potential.
Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).

Key exclusion criteria (17 listed)

History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
Participants with out-of-range, at-rest vital signs.
Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to Day 1.

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
PirtobrutinibAlso: LOXO-305, LY3527727Administered orally.	Drug	200 mg Pirtobrutinib (Sequence R/T), 200 mg Pirtobrutinib (Sequence T/R)

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-24 of Pirtobrutinib
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-t of Pirtobrutinib
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: AUC0-inf of Pirtobrutinib
PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: %AUCextrap of Pirtobrutinib
PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: CL/F of Pirtobrutinib
PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: t1/2 of Pirtobrutinib
PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Cmax of Pirtobrutinib
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Tmax of Pirtobrutinib
PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: λZ of Pirtobrutinib
PK: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Pirtobrutinib
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose
PK: Vz/F of Pirtobrutinib

Results and safety

Results posted to the registry on 13 Jan 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
200 mg Pirtobrutinib (Sequence R/T)	14	14
200 mg Pirtobrutinib (Sequence T/R)	14	14

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib

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

Measure	200 mg Pirtobrutinib (Reference Formulation) n = 28	200 mg Pirtobrutinib (Test Formulation) n = 28
Value	48800 (29.1)	49700 (20.6)

Population analysed: All randomized participants who received a dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib

Measure	200 mg Pirtobrutinib (Reference Formulation) n = 28	200 mg Pirtobrutinib (Test Formulation) n = 28
Value	81100 (36)	83600 (24.7)

Population analysed: All randomized participants who received a dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib

Measure	200 mg Pirtobrutinib (Reference Formulation) n = 28	200 mg Pirtobrutinib (Test Formulation) n = 28
Value	82000 (35.5)	84700 (24.4)

Population analysed: All randomized participants who received a dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed.

Primary outcome: PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib

Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: percentage of AUCextrap

Measure	200 mg Pirtobrutinib (Reference Formulation) n = 28	200 mg Pirtobrutinib (Test Formulation) n = 28
Value	1.01 (46.9)	1.12 (36.7)

Population analysed: All randomized participants who received a dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed.

Adverse events

Time frame: Baseline to Follow-up (Up To Day 24). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
200 mg Pirtobrutinib (Reference Formulation)	0 of 28 (0%)	0 of 28 (0%)	0 of 28
200 mg Pirtobrutinib (Test Formulation)	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 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.

Renee Ward, MD, PhD study director

Loxo Oncology, Inc.

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 Pirtobrutinib 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 17 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 13 Jan 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 13 Jan 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 Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib (time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose). The study lists 10 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 NCT06258174.

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 13 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.