Your session is about to expire
← Back to Search
Bruton's Tyrosine Kinase (BTK) Inhibitor
Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults
Phase 1
Waitlist Available
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing zanubrutinib in tablet and capsule forms to see how well each is absorbed and how food affects the tablet form. It is likely aimed at patients with certain blood cancers, and the medication works by stopping cancer cells from growing. Zanubrutinib is a medication approved for treating adults with a type of blood cancer who have already tried other treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Number of participants with clinically significant laboratory values
Number of participants with clinically significant vital sign measurements
Side effects data
From 2024 Phase 3 trial • 652 Patients • NCT0373401624%
Diarrhoea
20%
Hypertension
18%
Neutropenia
16%
COVID-19
16%
Arthralgia
15%
Anaemia
14%
Upper respiratory tract infection
13%
Muscle spasms
13%
Fatigue
12%
Rash
11%
Atrial fibrillation
10%
Thrombocytopenia
10%
Nausea
10%
Pyrexia
10%
Contusion
10%
Cough
10%
Headache
8%
Pneumonia
8%
Vomiting
8%
Urinary tract infection
7%
Pain in extremity
7%
Epistaxis
7%
Peripheral swelling
7%
Constipation
7%
Oedema peripheral
7%
Back pain
7%
Dizziness
6%
Dyspepsia
6%
Neutrophil count decreased
6%
Platelet count decreased
6%
Hyperuricaemia
6%
Decreased appetite
6%
Bronchitis
5%
Petechiae
5%
Abdominal pain
5%
Fall
5%
Hypokalaemia
5%
Insomnia
4%
Palpitations
4%
Blood pressure increased
4%
Dyspnoea
4%
Gastrooesophageal reflux disease
4%
COVID-19 pneumonia
4%
Cellulitis
4%
Haematuria
4%
Sinusitis
4%
Alanine aminotransferase increased
4%
Weight decreased
4%
Haematoma
4%
Oral herpes
4%
Myalgia
4%
Squamous cell carcinoma of skin
3%
Basal cell carcinoma
3%
Anxiety
3%
Nasopharyngitis
3%
Gout
3%
Oropharyngeal pain
3%
Paronychia
3%
Skin infection
3%
Paraesthesia
3%
Conjunctivitis
3%
Mouth ulceration
3%
Asthenia
3%
Pharyngitis
3%
Aspartate aminotransferase increased
3%
Productive cough
2%
Vertigo
2%
Pruritus
2%
Herpes zoster
2%
Cataract
2%
Blood creatinine increased
2%
Rash maculo-papular
2%
Hypogammaglobulinaemia
1%
Pleural effusion
1%
Mastoiditis
1%
Transient ischaemic attack
1%
Abdominal pain upper
1%
Death
1%
Adenocarcinoma gastric
1%
Lung adenocarcinoma
1%
Cerebral infarction
1%
Syncope
1%
Cardiac arrest
1%
Respiratory failure
1%
Influenza
1%
Hypoglobulinaemia
1%
Lymphadenopathy
1%
Angina pectoris
1%
Ventricular fibrillation
1%
Inguinal hernia
1%
Appendicitis
1%
Infection
1%
Pneumocystis jirovecii pneumonia
1%
Septic shock
1%
Haemolytic anaemia
1%
Subdural haematoma
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Myocardial infarction
1%
Skin laceration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibrutinib
Zanubrutinib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Low Dose CohortExperimental Treatment1 Intervention
Zanubrutinib will be administered as a single low dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences
Group II: High Dose CohortExperimental Treatment1 Intervention
Zanubrutinib will be administered as a single high dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~2160
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
BeiGeneLead Sponsor
198 Previous Clinical Trials
30,957 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,281 Previous Clinical Trials
500,459 Total Patients Enrolled