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

Healthy Clinical Trial

Official title:

A Phase I, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LOXO-305 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06181006
• Other study ID #: LOXO-BTK-20017
• Secondary ID: J2N-OX-JZNS
• Status: Completed
• Phase: Phase 1
• Start date: August 14, 2020
• Est. completion date: December 1, 2020

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 assess the safety and tolerability of pirtobrutinib (LOXO-305) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• 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

• 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

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	Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through 46 days
Secondary	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
Secondary	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
Secondary	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
Secondary	PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib	PK: %AUCextrap of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Secondary	PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib	PK: Cmax of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Secondary	PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib	PK: Tmax of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Secondary	PK: Apparent Terminal Elimination Rate Constant (?Z) of Pirtobrutinib	PK: ?Z of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Secondary	PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib	PK: CL/F of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Secondary	PK: Apparent Volume of Distribution at Terminal Phase (Vz/F) of Pirtobrutinib	PK: Vz/F of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Secondary	PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib	PK: t1/2 of Pirtobrutinib	Pre-dose up to 168 hours post-dose