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CompletedNCT06180980Updated Mar 7, 2025Results posted

A Study of the Effect of Food on Pirtobrutinib (LOXO-305) in Healthy Participants

A Phase 1 interventional study of Pirtobrutinib in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Jan 2021, registered Dec 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The main purpose of this study is to conduct blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib (LOXO-305) after meals and on an empty stomach. The study will also evaluate the safety and tolerability of pirtobrutinib (LOXO-305). Participants will stay in this study for up to 53 days (screening through follow-up call).

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive at Screening
  • Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
  • Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
  • Must have comply with all study procedures, including the 15-night stay at the Clinical Research Unit (CRU) and follow-up phone call

Exclusion criteria

Exclusion Criteria:

  • History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
  • Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
  • Positive polymerase chain reaction (PCR) test for COVID-19 at Screening
  • Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
  • Have previously received pirtobrutinib (LOXO-305) in any other study investigating pirtobrutinib (LOXO-305), within 30 days prior to Day 1
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    200 mg Pirtobrutinib: Treatment AB

    Participants received a single oral dose of 200 milligrams (mg) of pirtobrutinib administered in the morning on Day 1, under fasted conditions (Treatment A) followed by 200 mg pirtobrutinib administered orally in the morning on Day 8, under fed condition (Treatment B). A washout period of 7 days was maintained between Treatments A and B.

    Drug: Pirtobrutinib

  • Experimental
    200 mg Pirtobrutinib: Treatment BA

    Participants received a single oral dose of 200 mg pirtobrutinib administered in the morning on Day 1, under fed conditions (Treatment B) followed by 200 mg of pirtobrutinib administered orally in the morning on Day 8, under fasted conditions (Treatment A). A washout period of 7 days was maintained between Treatments A and B.

    Drug: Pirtobrutinib

Interventions

  • DrugPirtobrutinib

    Administered orally.

    Also known as: LOXO-305, LY3527727

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib

    PK: AUC0-24 of pirtobrutinib was reported.

    Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 1 and 8

  2. PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib

    PK: AUC0-t of pirtobrutinib was reported.

    Time frame: 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, and 168 hours post-dose on Days 1 and 8

  3. PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib

    PK: AUC0-inf of pirtobrutinib was reported.

    Time frame: 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, and 168 hours post-dose on Days 1 and 8

  4. PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib

    PK: %AUCextrap of pirtobrutinib was reported.

    Time frame: 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, and 168 hours post-dose on Days 1 and 8

  5. PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib

    PK: CL/F of pirtobrutinib was reported.

    Time frame: 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, and 168 hours post-dose on Days 1 and 8

  6. PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib

    PK: t½ of pirtobrutinib was reported.

    Time frame: 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, and 168 hours post-dose on Days 1 and 8

  7. PK: Maximum Observed Concentration (Cmax) of Pirtobrutinib

    PK: Cmax of pirtobrutinib was reported.

    Time frame: 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, and 168 hours post-dose on Days 1 and 8

  8. PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib

    PK: Tmax of pirtobrutinib was reported.

    Time frame: 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, and 168 hours post-dose on Days 1 and 8

  9. PK: Apparent Terminal Elimination Rate Constant (Lambda Z) of Pirtobrutinib

    PK: Lambda Z of pirtobrutinib was reported.

    Time frame: 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, and 168 hours post-dose on Days 1 and 8

  10. PK: Apparent Volume of Distribution at the Terminal Phase (Vz/F) of Pirtobrutinib

    PK: Vz/F of pirtobrutinib was reported

    Time frame: 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, and 168 hours post-dose on Days 1 and 8

07

Results

Posted Mar 7, 2025

Participant flow

Participant flow — Overall Study
Milestone200 mg Pirtobrutinib: Treatment AB200 mg Pirtobrutinib: Treatment BA
Started1010
Received at least 1 dose of study drug1010
Completed1010
Not completed00

Outcome measures

PrimaryPharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib

PK: AUC0-24 of pirtobrutinib was reported.

Time frame:
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 1 and 8
Reported as:
Geometric mean · hour nanogram per milliliter (h*ng/mL)
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib
hour nanogram per milliliter (h*ng/mL)200 mg Pirtobrutinib (Fasted)200 mg Pirtobrutinib (Fed)
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib51700 ± 18.745500 ± 42.0
PrimaryPK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib

PK: AUC0-t of pirtobrutinib was reported.

Time frame:
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, and 168 hours post-dose on Days 1 and 8
Reported as:
Geometric mean · h*ng/mL
PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib
h*ng/mL200 mg Pirtobrutinib (Fasted)200 mg Pirtobrutinib (Fed)
PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib83900 ± 25.177800 ± 48.9
PrimaryPK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib

PK: AUC0-inf of pirtobrutinib was reported.

Time frame:
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, and 168 hours post-dose on Days 1 and 8
Reported as:
Geometric mean · h*ng/mL
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib
h*ng/mL200 mg Pirtobrutinib (Fasted)200 mg Pirtobrutinib (Fed)
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib85100 ± 25.079000 ± 48.3
PrimaryPK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib

PK: %AUCextrap of pirtobrutinib was reported.

Time frame:
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, and 168 hours post-dose on Days 1 and 8
Reported as:
Geometric mean · percentage of AUCextrap
PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib
percentage of AUCextrap200 mg Pirtobrutinib (Fasted)200 mg Pirtobrutinib (Fed)
PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib1.21 ± 43.71.25 ± 65.1
PrimaryPK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib

PK: CL/F of pirtobrutinib was reported.

Time frame:
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, and 168 hours post-dose on Days 1 and 8
Reported as:
Geometric mean · liter per hour (L/h)
PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib
liter per hour (L/h)200 mg Pirtobrutinib (Fasted)200 mg Pirtobrutinib (Fed)
PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib2.35 ± 25.02.53 ± 48.3
PrimaryPK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib

PK: t½ of pirtobrutinib was reported.

Time frame:
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, and 168 hours post-dose on Days 1 and 8
Reported as:
Geometric mean · hour
PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib
hour200 mg Pirtobrutinib (Fasted)200 mg Pirtobrutinib (Fed)
PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib18.4 ± 22.219.2 ± 25.4
PrimaryPK: Maximum Observed Concentration (Cmax) of Pirtobrutinib

PK: Cmax of pirtobrutinib was reported.

Time frame:
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, and 168 hours post-dose on Days 1 and 8
Reported as:
Geometric mean · nanogram per milliliter (ng/mL)
PK: Maximum Observed Concentration (Cmax) of Pirtobrutinib
nanogram per milliliter (ng/mL)200 mg Pirtobrutinib (Fasted)200 mg Pirtobrutinib (Fed)
PK: Maximum Observed Concentration (Cmax) of Pirtobrutinib4200 ± 18.63250 ± 35.9
PrimaryPK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib

PK: Tmax of pirtobrutinib was reported.

Time frame:
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, and 168 hours post-dose on Days 1 and 8
Reported as:
Median · hour
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib
hour200 mg Pirtobrutinib (Fasted)200 mg Pirtobrutinib (Fed)
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib3.00 (1.50 to 4.05)4.00 (2.50 to 8.00)
PrimaryPK: Apparent Terminal Elimination Rate Constant (Lambda Z) of Pirtobrutinib

PK: Lambda Z of pirtobrutinib was reported.

Time frame:
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, and 168 hours post-dose on Days 1 and 8
Reported as:
Number · 1/hour (1/h)
PK: Apparent Terminal Elimination Rate Constant (Lambda Z) of Pirtobrutinib
1/hour (1/h)200 mg Pirtobrutinib (Fasted)200 mg Pirtobrutinib (Fed)
Subject 10.01990.0155
Subject 20.03550.0363
Subject 30.03080.0303
Subject 40.04570.0436
Subject 50.04730.0352
Subject 60.03330.0307
Subject 70.03940.0381
Subject 80.04270.0459
Subject 90.04040.0395
Subject 100.03150.0365
Subject 110.05540.0513
Subject 120.03020.0344
Subject 130.03310.0265
Subject 140.03620.0383
Subject 150.03820.0396
Subject 160.04660.0381
Subject 170.03920.0440
Subject 180.04320.0418
Subject 190.04080.0397
Subject 200.04080.0360
PrimaryPK: Apparent Volume of Distribution at the Terminal Phase (Vz/F) of Pirtobrutinib

PK: Vz/F of pirtobrutinib was reported

Time frame:
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, and 168 hours post-dose on Days 1 and 8
Reported as:
Geometric mean · liter
PK: Apparent Volume of Distribution at the Terminal Phase (Vz/F) of Pirtobrutinib
liter200 mg Pirtobrutinib (Fasted)200 mg Pirtobrutinib (Fed)
PK: Apparent Volume of Distribution at the Terminal Phase (Vz/F) of Pirtobrutinib62.5 ± 21.270.1 ± 43.4

Adverse events

Collected over Baseline to end of follow-up (up to 24 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
200 mg Pirtobrutinib (Fasted)0/20 (0%)0/20 (0%)2/20 (10%)
200 mg Pirtobrutinib (Fed)0/20 (0%)0/20 (0%)2/20 (10%)
Most frequent other events
Most frequent other events
Event200 mg Pirtobrutinib (Fasted)200 mg Pirtobrutinib (Fed)
DizzinessNervous system disorders1/200/20
DysgeusiaNervous system disorders1/200/20
HeadacheNervous system disorders0/201/20
DiarrhoeaGastrointestinal disorders0/201/20
Dry mouthGastrointestinal disorders0/201/20
PetechiaeSkin and subcutaneous tissue disorders1/200/20

Baseline characteristics

All participants who received at least 1 dose of Pirtobrutinib.

Age, Continuous
Age, Continuous(years)200 mg Pirtobrutinib: Treatment AB200 mg Pirtobrutinib: Treatment BATotal
Mean35.9 ± 10.1035.9 ± 11.1035.9 ± 10.33
Sex: Female, Male
Sex: Female, Male(Participants)200 mg Pirtobrutinib: Treatment AB200 mg Pirtobrutinib: Treatment BATotal
Female224
Male8816
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)200 mg Pirtobrutinib: Treatment AB200 mg Pirtobrutinib: Treatment BATotal
Hispanic or Latino6713
Not Hispanic or Latino437
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)200 mg Pirtobrutinib: Treatment AB200 mg Pirtobrutinib: Treatment BATotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American325
White6814
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)200 mg Pirtobrutinib: Treatment AB200 mg Pirtobrutinib: Treatment BATotal
United States101020
08

Study locations

1 site
  • Covance Clinical Research Unit
    Daytona Beach, Florida 32117, United States
09

References and documents

Study documents

  • Study protocol · Dec 2, 2020
  • Statistical analysis plan · May 11, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06180980
Lead sponsor
Eli Lilly and Company
Collaborators
Loxo Oncology, Inc.
Responsible party
Sponsor
First posted
Dec 26, 2023
Start date
Jan 4, 2021
Primary completion
Mar 8, 2021
Completion
Mar 8, 2021
Results posted
Mar 7, 2025
Last update
Mar 7, 2025

Study contacts

Renee Ward, MD, PhD
study director · Loxo Oncology, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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