A Study of Two Different Formulations of Pirtobrutinib (LOXO-305) In Healthy Participants

Healthy Clinical Trial

Official title:

A Phase I, Open-Label, Randomized, 2-Way Crossover Study to Compare the PK of Pirtobrutinib (LOXO-305) Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06258174
• Other study ID #: LOXO-BTK-21050
• Secondary ID: J2N-OX-JZNV
• Status: Completed
• Phase: Phase 1
• Start date: September 28, 2021
• Est. completion date: December 22, 2021

Study information

• Verified date: February 2024
• 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 compare two different formulations (mixtures) of pirtobrutinib (LOXO-305) in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will be collected. The study will last up to 65 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 22, 2021
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Males and females of non-childbearing potential.

• Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).

• Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).

Exclusion Criteria:

• History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:

1. liver disease

2. pancreatitis

3. peptic ulcer disease

4. intestinal malabsorption

5. cholecystectomy

6. gastric reduction surgery

7. history or presence of clinically significant cardiovascular disease.

• Participants with out-of-range, at-rest vital signs.

• Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).

• Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.

• Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to Day 1.

• Use or intention to use any prescription or over-the-counter medications within 14 days prior to Day 1 and through end of trial.

• History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.

• Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.

• Receipt of blood products within 2 months prior to Check-in (Day -1).

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Pirtobrutinib
Administered orally.

Locations

Country	Name	City	State
United States	Labcorp Drug Development	Dallas	Texas

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 168 hours post-dose
Primary	PK: Area Under the Concentration-time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib	PK: AUC0-t of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Primary	PK: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib	PK: AUC0-inf of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Primary	PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib	PK: %AUCextrap of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Primary	PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib	PK: CL/F of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Primary	PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib	PK: t1/2 of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Primary	PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib	PK: Cmax of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Primary	PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib	PK: Tmax of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Primary	PK: Apparent Terminal Elimination Rate Constant (?Z) of Pirtobrutinib	PK: ?Z of Pirtobrutinib	Pre-dose up to 168 hours post-dose
Primary	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