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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06180980
• Other study ID #: LOXO-BTK-20009
• Secondary ID: J2N-MC-JZNK
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2021
• Est. completion date: March 8, 2021

Study information

• Verified date: December 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Pirtobrutinib
Administered orally.

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Daytona Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pre-dose up to 24 hours post-dose on Days 1 and 8
Primary	PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib	PK: AUC0-t of Pirtobrutinib	Pre-dose up to 168 hours post-dose on Days 1 and 8
Primary	PK: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib	PK: AUC0-inf of Pirtobrutinib	Pre-dose up to 168 hours post-dose on Days 1 and 8
Primary	PK: Percentage of AUC0-inf extrapolated (AUC%extrap) of Pirtobrutinib	PK: AUC%extrap of Pirtobrutinib	Pre-dose up to 168 hours post-dose on Days 1 and 8
Primary	PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib	PK: CL/F of Pirtobrutinib	Pre-dose up to 168 hours post-dose on Days 1 and 8
Primary	PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib	PK: t½ of Pirtobrutinib	Pre-dose up to 168 hours post-dose on Days 1 and 8
Primary	PK: Maximum observed concentration (Cmax) of Pirtobrutinib	PK: Cmax of Pirtobrutinib	Pre-dose up to 168 hours post-dose on Days 1 and 8
Primary	PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib	PK: Tmax of Pirtobrutinib	Pre-dose up to 168 hours post-dose on Days 1 and 8
Primary	PK: Apparent Terminal Elimination Rate Constant (Lambda Z) of Pirtobrutinib	PK: Lambda Z of Pirtobrutinib	Pre-dose up to 168 hours post-dose on Days 1 and 8
Primary	PK: Apparent Volume of Distribution at the Terminal Phase (Vz/F) of Pirtobrutinib	PK: Vz/F of Pirtobrutinib	Pre-dose up to 168 hours post-dose on Days 1 and 8