Phase 1
Completed N=20
A Study of the Effect of Food on Pirtobrutinib (LOXO-305) in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT06180980 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib — 51700; 45500 hour nanogram per milliliter (h*ng/mL)
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib |
51700; 45500 | — |
| PRIMARY PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib |
83900; 77800 | — |
| PRIMARY PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib |
85100; 79000 | — |
| PRIMARY PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib |
1.21; 1.25 | — |
| PRIMARY PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib |
2.35; 2.53 | — |
| PRIMARY PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib |
18.4; 19.2 | — |
| PRIMARY PK: Maximum Observed Concentration (Cmax) of Pirtobrutinib |
4200; 3250 | — |
| PRIMARY PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib |
3.00; 4.00 | — |
| PRIMARY PK: Apparent Terminal Elimination Rate Constant (Lambda Z) of Pirtobrutinib |
0.0199; 0.0155; 0.0355; 0.0363; 0.0308; 0.0303 | — |
| PRIMARY PK: Apparent Volume of Distribution at the Terminal Phase (Vz/F) of Pirtobrutinib |
62.5; 70.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06180980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.