Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Brigatinib Formulations for Healthy Subjects
Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
Study Summary
This trial will compare how much of a drug is absorbed into the bloodstream when taken as a solution vs. a tablet.
Who is the study for?
This trial is for healthy adults who haven't smoked or used nicotine in the last 3 months, have a BMI between 18.0 and <32.0 kg/m2, normal heart rate and blood pressure, and no major surgery history. They must not take any drugs or supplements within 28 days before the study starts and can't have HIV, Hepatitis B/C, or COVID-19.Check my eligibility
What is being tested?
The study aims to compare how much brigatinib gets into the bloodstream when taken as a liquid solution versus as a tablet by healthy adults after one dose.See study design
What are the potential side effects?
Since this trial involves healthy volunteers rather than patients with an illness, side effects are monitored closely but may include typical drug reactions such as digestive discomfort, headaches, dizziness or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Brigatinib
AUC∞: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity for Brigatinib
Cmax: Maximum Observed Plasma Concentration for Brigatinib
Secondary outcome measures
Number of Participants with at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Side effects data
From 2021 Phase 3 trial • 275 Patients • NCT0273750157%
Diarrhoea
50%
Blood Creatine Phosphokinase Increased
36%
Cough
32%
Hypertension
32%
Nausea
26%
Back Pain
26%
Aspartate Aminotransferase Increased
23%
Headache
23%
Dyspnoea
23%
Alanine Aminotransferase Increased
23%
Lipase Increased
22%
Vomiting
21%
Fatigue
21%
Pruritus
20%
Arthralgia
19%
Constipation
18%
Rash
17%
Dizziness
15%
Muscle Spasms
15%
Pyrexia
13%
Upper Respiratory Tract Infection
13%
Abdominal Pain
13%
Blood Alkaline Phosphatase Increased
13%
Asthenia
12%
Decreased Appetite
11%
Dyspepsia
11%
Musculoskeletal Pain
10%
Insomnia
10%
Dermatitis Acneiform
10%
Myalgia
10%
Oedema Peripheral
10%
Blood Cholesterol Increased
10%
Oropharyngeal Pain
9%
Productive Cough
9%
Nasopharyngitis
9%
Anaemia
9%
Paraesthesia
9%
Stomatitis
9%
Musculoskeletal Chest Pain
8%
Non-Cardiac Chest Pain
8%
Abdominal Pain Upper
7%
Urinary Tract Infection
7%
Bradycardia
7%
Epistaxis
7%
Pneumonia
7%
Pain In Extremity
7%
Rash Erythematous
6%
Dry Skin
6%
Rash Maculo-Papular
6%
Dysphonia
6%
Electrocardiogram Qt Prolonged
6%
Dry Mouth
6%
Eczema
6%
Blood Creatinine Increased
5%
Sinus Bradycardia
5%
Respiratory Tract Infection
5%
Hyperglycaemia
5%
Hypokalaemia
5%
Hypercholesterolaemia
5%
Vision Blurred
5%
Blood Lactate Dehydrogenase Increased
5%
Hypophosphataemia
5%
Rhinorrhoea
5%
Malaise
4%
Depression
4%
Dysgeusia
4%
Influenza Like Illness
4%
Peripheral Swelling
4%
Gamma-Glutamyltransferase Increased
4%
Neoplasm Progression
2%
Neutrophil Count Decreased
2%
Pulmonary Embolism
2%
Pleural Effusion
2%
Interstitial Lung Disease
2%
Hypocalcaemia
2%
Hypoaesthesia
2%
Taste Disorder
2%
Hypotension
1%
Toxicity To Various Agents
1%
Appendicitis
1%
Gastroenteritis
1%
Lower Respiratory Tract Infection
1%
Visual Impairment
1%
Disseminated Intravascular Coagulation
1%
Confusional State
1%
Cerebrovascular Accident
1%
Dysarthria
1%
Encephalopathy
1%
Peripheral Sensory Neuropathy
1%
Cholestasis
1%
Muscular Weakness
1%
Malignant Pleural Effusion
1%
Cancer Pain
1%
Diffuse Large B-Cell Lymphoma
1%
Invasive Breast Carcinoma
1%
Lung Neoplasm Malignant
1%
Ovarian Cancer Stage I
1%
Neutropenia
1%
Gout
1%
Syncope
1%
Seizure
1%
Memory Impairment
1%
Vocal Cord Paralysis
1%
Pericardial Effusion
1%
Cardiac Tamponade
1%
Acute Myocardial Infarction
1%
Angina Pectoris
1%
Arrhythmia
1%
Pneumonitis
1%
Pneumonia Aspiration
1%
Pneumothorax
1%
Pulmonary Oedema
1%
Dysphagia
1%
Inguinal Hernia
1%
Neutropenic Colitis
1%
Oesophageal Obstruction
1%
Cholecystitis
1%
Bile Duct Stone
1%
Multiple Organ Dysfunction Syndrome
1%
Sudden Death
1%
C-Reactive Protein Increased
1%
Transaminases Abnormal
1%
Femoral Neck Fracture
1%
Fall
1%
Ligament Rupture
1%
Hypoalbuminaemia
1%
Viral Infection
1%
Metastases To Meninges
1%
Lung Adenocarcinoma
1%
Squamous Cell Carcinoma Of Skin
1%
Hypoglycaemia
1%
Delirium
1%
Balance Disorder
1%
Partial Seizures
1%
Atrial Fibrillation
1%
Hepatocellular Injury
1%
Acute Kidney Injury
1%
Photopsia
1%
Metastases To Central Nervous System
1%
Hyperkalaemia
1%
Cognitive Disorder
1%
Gastric Haemorrhage
1%
Mucosal Inflammation
1%
Gastrooesophageal Reflux Disease
1%
Respiratory Distress
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized Phase: Brigatinib 90 mg QD/180 QD
Randomized Phase: Crizotinib 250 mg BID
Crossover Phase: Brigatinib 90 mg QD/180 mg QD
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment B followed by Treatment AExperimental Treatment1 Intervention
Participants will receive 90 mg tablet of brigatinib in a fasted state on Day 1 of Period 1 (Treatment B) followed by a washout period of at least 14 days and will receive 90 mg oral solution of brigatinib in a fasted state on Day 1 of Period 2 (Treatment A).
Group II: Treatment A followed by Treatment BExperimental Treatment1 Intervention
Participants will receive 90 mg oral solution of brigatinib in a fasted state on Day 1 of Period 1 (Treatment A) followed by a washout period of at least 14 days and will receive 90 mg tablet of brigatinib in a fasted state on Day 1 of Period 2 (Treatment B).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brigatinib
2018
Completed Phase 3
~890
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,250 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,668 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any additional vacancies in the current experiment?
"The clinicaltrials.gov database reveals that this particular trial, first posted on December 18th 2023, is not presently recruiting patients. However, there are 844 ongoing studies seeking participants at the current moment."
Answered by AI
Is there any evidence to suggest that the sequence of Treatment B followed by Treatment A is a secure option for individuals?
"Because this is a Phase 1 trial, our Power team assigned Treatment B followed by Treatment A the lowest possible assessment of safety at a score of 1 due to limited evidence for efficacy and security."
Answered by AI
Does the age limit for enrollment in this trial exceed twenty years?
"This clinical trial is accepting patients aged 18 and over, yet not exceeding the age of 55."
Answered by AI
Can I enter the clinical trial according to its criteria?
"Prospective enrollees for this medical experiment must be between eighteen and fifty-five years old, in addition to being medically sound. Currently, the study is looking for a dozen participants."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger