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Anti-inflammatory

Brensocatib for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Insmed Incorporated
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 pre-dose and at multiple timepoints post-dose on days 1 to 4 in each period
Awards & highlights

Study Summary

The study has 2 Parts: The primary purpose of Part 1 is to determine the supratherapeutic dose of brensocatib to be used in Part 2 of the study. The primary purpose of Part 2 is to assess brensocatib's potential for prolonging the QT interval.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and at multiple timepoints post-dose on days 1 to 4 in each period
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and at multiple timepoints post-dose on days 1 to 4 in each period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Number of Participants who Experienced at least one Treatment-Emergent Adverse Event (TEAE) as Assessed by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Part 2: Placebo- and Baseline-Corrected QTcF (ΔΔQTcF)
Secondary outcome measures
Part 2: Number of Participants With Categorical Outliers for ECG Parameters: HR, PR, QRS, and QTcF
Part 2: Number of Participants who Experienced at least one TEAE
Parts 1 and 2: AUC From Time Zero Extrapolated to Infinity (AUC∞) of Brensocatib
+7 more

Side effects data

From 2021 Phase 3 trial • 406 Patients • NCT04817332
14%
Infections
4%
Respiratory disorders
3%
Rash
2%
Nausea
2%
Hyperglycaemia
2%
Dyspepsia
2%
Nervous system disorders
2%
Epistaxis
2%
Dizziness
1%
Pruritus
1%
Peripheral swelling
1%
Glossodynia
1%
Oedema peripheral
1%
Extravasation
1%
Hepatic function abnormal
1%
Swollen tongue
1%
Dyspnoea
1%
Supraventricular tachycardia
1%
Vomiting
1%
Constipation
1%
Gastrooesophageal reflux disease
1%
Arthralgia
1%
Serratia infection
1%
Hallucination, visual
1%
Nightmare
1%
Respiratory tract infection
1%
Gastrointestinal disorders
1%
Gastritis erosive
1%
General disorders
1%
Skin disorders
1%
Vascular disorders
1%
Chronic lymphocytic leukaemia
1%
Peripheral ischaemia
1%
Chest discomfort
1%
Swelling face
1%
Hiccups
1%
Pneumothorax
1%
Rhinorrhoea
1%
Pulmonary embolism
1%
Alanine aminotransferase increased
1%
Liver function test abnormal
1%
Glycosylated haemoglobin increased
1%
Blood glucose abnormal
1%
Transaminases increased
1%
Fall
1%
Bradycardia
1%
Palpitations
1%
Tachyarrhythmia
1%
Acute coronary syndrome
1%
Sinus bradycardia
1%
Headache
1%
Memory impairment
1%
Paraesthesia
1%
Vision blurred
1%
Dry mouth
1%
Gingival bleeding
1%
Hypoaesthesia oral
1%
Lip pain
1%
Mouth ulceration
1%
Subcutaneous emphysema
1%
Dry skin
1%
Rash pruritic
1%
Acute kidney injury
1%
Back pain
1%
Muscle spasms
1%
Clostridium difficile colitis
1%
Candida infection
1%
Pneumonia
1%
Urinary tract infection
1%
Staphylococcal bacteraemia
1%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brensocatib
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment3 Interventions
Participants will be randomized to 1 of 4 treatment sequences (ABCD, BDAC, CADB, DCBA).
Group II: Part 1: Treatment Dose 2Experimental Treatment2 Interventions
Participants (in a 3:1 ratio) will receive a single oral dose of brensocatib Dose 2 or placebo, once on Day 1.
Group III: Part 1: Treatment Dose 1Experimental Treatment2 Interventions
Participants (in a 3:1 ratio) will receive a single oral dose of brensocatib Dose 1 or placebo, once on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brensocatib
2023
Completed Phase 3
~620
Moxifloxacin
2013
Completed Phase 4
~3290
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Insmed IncorporatedLead Sponsor
42 Previous Clinical Trials
7,154 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Participants
2022. "A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05355935.
~16 spots leftby May 2025
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