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Bruton's Tyrosine Kinase (BTK) Inhibitor

Sequence 1 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 predose and up to 48 hours postdose up to day 10
Awards & highlights

Study Summary

This trial tested a new tablet form of a medicine to make sure it is just as effective as the original capsule form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and up to 48 hours postdose up to day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and up to 48 hours postdose up to day 10 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)
Number of participants with clinically significant electrocardiogram (ECG) results
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%
Gout
3%
Nasopharyngitis
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%
Transient ischaemic attack
1%
Cerebral infarction
1%
Adenocarcinoma gastric
1%
Cardiac arrest
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: Sequence 2Experimental Treatment1 Intervention
Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.
Group II: Sequence 1Experimental Treatment1 Intervention
Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.
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
28,756 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,207 Previous Clinical Trials
489,622 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 participants aged 80 and above being accepted for this experiment?

"The lower and upper age limit for this trial is 18 and 65 respectively, as specified in the inclusion criteria."

Answered by AI

Am I eligible to join this clinical trial?

"Eligible participants should be of sound health and aged between 18-65. This research is currently seeking to enlist 58 individuals in the experiment."

Answered by AI

Has Sequence 1 been accepted by the FDA as a viable treatment?

"As Sequence 1 is currently in its Phase 1 trial, there is limited evidence to support the efficacy and safety of this medication. Consequently, it received a score of only 1 out of 3 on our team's scale."

Answered by AI

Are any more participants being sought for this clinical exploration?

"Accurate. The trial's information on clinicaltrials.gov reveals that it is actively recruiting patients, with the initial post date being March 7th 2023 and the last update occurring two days later."

Answered by AI

What is the maximum capacity for participants in this clinical experiment?

"Correct. Clinicaltrials.gov lists this medical study, which was published on March 7th 2023, as actively recruiting for participants. The trial seeks 58 patients from 2 designated clinical sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants
2023. "Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05767398.
~28 spots leftby Apr 2025
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