Status:
COMPLETED
A Study to Compare the Relative Bioavailability of Brigatinib When Swallowed as a Solution Versus When Swallowed as a Tablet in Healthy Adults
Lead Sponsor:
Takeda
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
The drug being tested in this study is called brigatinib. Brigatinib is being tested to assess its relative bioavailability when administered as an oral solution versus as an immediate-release tablet ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06132867
Start Date
December 20 2023
End Date
February 17 2024
Last Update
January 23 2025
Active Locations (1)
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1
Celerion, Inc.
Tempe, Arizona, United States, 85283