A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pirtobrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06181006

J2N-OX-JZNS (Other Identifier)

LOXO-BTK-20017

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously completed or withdrawn from any other study investigating Pirtobrutinib (LOXO-305) and have previously received the investigational product

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Cohort 1: 300 mg Pirtobrutinib

Experimental group

Description:

Participants received a single dose of Pirtobrutinib 300 milligram (mg) administered orally on Day 1.

Treatment:

Drug: Pirtobrutinib

Cohort 2: 600 mg Pirtobrutinib

Experimental group

Description:

Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.

Treatment:

Drug: Pirtobrutinib

Cohort 3: 800 mg Pirtobrutinib

Experimental group

Description:

Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.

Treatment:

Drug: Pirtobrutinib

Cohort 4: 900 mg Pirtobrutinib

Experimental group

Description:

Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.

Treatment:

Drug: Pirtobrutinib