Phase 1
Completed N=24
A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants
Healthy
Source: ClinicalTrials.gov NCT06181006 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) — 1; 0; 0; 3 Participants
Summary
The main purpose of this study is to assess the safety and tolerability of pirtobrutinib and to look at the amount of the study drug, pirtobrutinib, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 46 days, including screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) |
1; 0; 0; 3; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib |
84100; 135000; 200000; 225000 | — |
| SECONDARY PK: Area Under the Concentration Versus Time Curve From Hour Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib |
143000; 259000; 379000; 490000 | — |
| SECONDARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib |
144000; 260000; 382000; 492000 | — |
| SECONDARY PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib |
0.869; 0.504; 0.474; 0.458 | — |
| SECONDARY PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib |
6600; 9050; 13700; 13000 | — |
| SECONDARY PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib |
3.25; 2.75; 3.00; 4.01 | — |
| SECONDARY PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 1) |
0.0367; 0.0423; 0.0242; 0.0477; 0.0285; 0.0469 | — |
| SECONDARY PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 2) |
0.0322; 0.0317; 0.0381; 0.0327; 0.0353; 0.0368 | — |
| SECONDARY PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 3) |
0.0279; 0.0263; 0.0339; 0.0339; 0.0295; 0.0410 | — |
| SECONDARY PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 4) |
0.0291; 0.0367; 0.0330; 0.0313; 0.0320; 0.0396 | — |
| SECONDARY PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib |
2.08; 2.31; 2.10; 1.83 | — |
| SECONDARY PK: Apparent Volume of Distribution at Terminal Phase (Vz/F) of Pirtobrutinib |
57.0; 67.1; 66.1; 54.7 | — |
| SECONDARY PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib |
19.0; 20.2; 21.9; 20.7 | — |
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
- 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 8-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 or Check-in (Day -1)
- 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 completed or withdrawn from any other study investigating Pirtobrutinib (LOXO-305) and have previously received the investigational product
Data sourced from ClinicalTrials.gov (NCT06181006). 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.