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Bruton's Tyrosine Kinase (BTK) Inhibitor

Zanubrutinib for Healthy Subjects

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

Study Summary

This trial will compare the levels of a new cancer drug in the blood when given as a tablet or capsule, and whether taking the drug with food affects absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent oral clearance (CL/F)
Apparent terminal elimination half-life (t1/2)
Apparent volume of distribution (Vz/F)
+5 more
Secondary outcome measures
Number of participants with adverse events (AEs)
Electrocardiogram
Number of participants with clinically significant laboratory values
+1 more

Side effects data

From 2024 Phase 3 trial • 652 Patients • NCT03734016
24%
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%
Pyrexia
10%
Thrombocytopenia
10%
Nausea
10%
Contusion
10%
Cough
10%
Headache
8%
Pneumonia
8%
Vomiting
8%
Urinary tract infection
7%
Epistaxis
7%
Pain in extremity
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%
Abdominal pain
5%
Fall
5%
Hypokalaemia
5%
Insomnia
5%
Petechiae
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%
Nasopharyngitis
3%
Gout
3%
Basal cell carcinoma
3%
Oropharyngeal pain
3%
Anxiety
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%
Herpes zoster
2%
Cataract
2%
Blood creatinine increased
2%
Pruritus
2%
Rash maculo-papular
2%
Hypogammaglobulinaemia
1%
Cerebral infarction
1%
Cardiac arrest
1%
Transient ischaemic attack
1%
Adenocarcinoma gastric
1%
Respiratory failure
1%
Syncope
1%
Lung adenocarcinoma
1%
Death
1%
Pleural effusion
1%
Abdominal pain upper
1%
Influenza
1%
Hypoglobulinaemia
1%
Lymphadenopathy
1%
Angina pectoris
1%
Ventricular fibrillation
1%
Inguinal hernia
1%
Appendicitis
1%
Infection
1%
Mastoiditis
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

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
~1940

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BeiGeneLead Sponsor
175 Previous Clinical Trials
28,771 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,207 Previous Clinical Trials
489,637 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults
2022. "Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05547399.
~15 spots leftby Apr 2025
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