A Study to Compare the Relative Bioavailability of Brigatinib When Swallowed as a Solution Versus When Swallowed as a Tablet in Healthy Adults

ABSTRACT

ConditionHealthy Volunteers

InterventionDrug Brigatinib;Drug Brigatinib

Primary outcome:Cmax Maximum Observed Plasma Concentration for Brigatinib;AUClast Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Brigatinib;AUC8 Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity for Brigatinib

Criteria
Inclusion Criteria

1. Continuous nonsmoker who has not used nicotine-containing products for at least 3
months prior to the first dosing and throughout the study.

2. Body mass index (BMI) =18.0 and ?32.0 kilograms per meters squared (kg/m^2) at
screening.

3. Pulse rate between 60 and 100 beats per minute (bpm) and a blood pressure between 90
to 140 millimeters of mercury (mmHg) systolic and 40 to 90 mmHg diastolic at screening
and prior to dosing of Period 1.

4. Creatine phosphokinase is =1.1x upper limit of normal [ULN]; lipase, amylase, alanine
aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, glucose,
and activated partial thromboplastin time (aPTT) are =ULN at screening and check-in of
Period 1.

Exclusion Criteria

1. Any history of major surgery.

2. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or
related compounds.

3. Unable to refrain from or anticipates the use of any drug, including prescription and
nonprescription medications, herbal remedies, or vitamin supplements within 28 days
prior to the first dosing and throughout the study.

4. Positive results at screening for Human Immunodeficiency Virus (HIV), Hepatitis B
surface Antigen (HBsAg), or Hepatitis C Virus (HCV).

5. Positive coronavirus disease 2019 (COVID-19) results at first check-in.

6. Donation of blood or significant blood loss within 56 days prior to the first dosing.

7. Plasma donation within 7 days prior to the first dosing.