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

• Status: Completed
• Trial end date: 2024-02-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Takeda

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.