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Completed

NCT Number: NCT06180980

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

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).

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Pirtobrutinib

Drug

Administered orally.

Other names: LOXO-305, LY3527727

Primary outcomes

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

    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

    PK: AUC0-24 of pirtobrutinib was reported.

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

    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

    PK: AUC0-t of pirtobrutinib was reported.

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

    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

    PK: AUC0-inf of pirtobrutinib was reported.

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

    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

    PK: %AUCextrap of pirtobrutinib was reported.

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

    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

    PK: CL/F of pirtobrutinib was reported.

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

    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

    PK: t½ of pirtobrutinib was reported.

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

    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

    PK: Cmax of pirtobrutinib was reported.

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

    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

    PK: Tmax of pirtobrutinib was reported.

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

    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

    PK: Lambda Z of pirtobrutinib was reported.

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

    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

    PK: Vz/F of pirtobrutinib was reported

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Loxo Oncology, Inc.

Registry information

Official study title

A Phase I, Open-Label, Randomized, 2-Way Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Pirtobrutinib (LOXO-305) in Healthy Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 26, 2023
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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