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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06132867
• Other study ID #: Brigatinib-1004
• Status: Completed
• Phase: Phase 1
• Start date: January 17, 2024
• Est. completion date: February 14, 2024

Study information

• Verified date: February 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 14, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Brigatinib
Brigatinib oral solution
• Brigatinib
Brigatinib tablet

Locations

Country	Name	City	State
United States	Celerion, Inc.	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum Observed Plasma Concentration for Brigatinib		Predose at Day 1 and multiple times (up to 168 hours) post dose up to Day 8 of Period 1 and Period 2 (Each Period length= 8 days)
Primary	AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Brigatinib		Predose at Day 1 and multiple times (up to 168 hours) post dose up to Day 8 of Period 1 and Period 2 (Each Period length= 8 days)
Primary	AUC8: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity for Brigatinib		Predose at Day 1 and multiple times (up to 168 hours) post dose up to Day 8 of Period 1 and Period 2 (Each Period length= 8 days)
Secondary	Number of Participants with at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent form (ICF) to participate in a study. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or is an important medical event.	From signing of informed consent to 14 (±2) days after last dose (up to 56 days)

External Links

•   To obtain more information on the study, click this link.