NCT06132867

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

A Phase 1, Open-Label, Randomized, Single-Dose, 2-Period, Crossover Study to Evaluate the Relative Bioavailability of Brigatinib Administered as an Oral Solution Versus an Immediate-Release Tablet in Adult Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 in healthy participants. The study will enroll approximately 12 participants. Participants will be randomly assigned to one of the treatment sequences: * Sequence 1: Treatment A followed by Treatment B * Sequence 2: Treatment B followed by Treatment A wherein Treatment A is a 90 mg oral solution dose and Treatment B is a 90 mg tablet dose. There will be a washout period of at least 14 days between brigatinib administration in each study period. The follow-up contact will occur 14 (±2) days post the last dose of study drug. This single-center trial will be conducted in the United States. The overall study duration is approximately 56 days.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Brigatinib	Brigatinib oral solution
DRUG	Brigatinib	Brigatinib tablet

Timeline

• Start date: 2023-12-20
• Primary completion: 2024-02-17
• Completion: 2024-02-17
• First posted: 2023-11-15
• Last updated: 2025-01-23
• Results posted: 2025-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study