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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

The main aim of this study is to compare the amount of brigatinib in the blood of healthy adults after they have swallowed one dose either as a solution or as a tablet.

Key facts

Study ID

NCT06132867

Run by

Takeda

People needed

12

Starts

2023-12-20

Expected to finish

2024-02-17

Last updated by the study team

2025-01-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study.
• Body mass index (BMI) ≥18.0 and ˂32.0 kilograms per meters squared (kg/m\^2) at screening.
• 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.
• 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.

You may not qualify if…

• Any history of major surgery.
• History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
• 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.
• Positive results at screening for Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV).
• Positive coronavirus disease 2019 (COVID-19) results at first check-in.
• Donation of blood or significant blood loss within 56 days prior to the first dosing.
• Plasma donation within 7 days prior to the first dosing.

Where it is running

• Celerion, Inc. — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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