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Anti-inflammatory

Brensocatib for Liver Disease

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 9
Awards & highlights

Study Summary

This trial is comparing how well a new drug is absorbed in people with different levels of liver function.

Eligible Conditions
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and at multiple timepoints post-dose on days 1 to 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and at multiple timepoints post-dose on days 1 to 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration Time Curve (AUC)
Secondary outcome measures
Fraction Unbound (Fu)
Number of Participants who Experienced at Least one Adverse Event (AE)

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%
Glossodynia
1%
Oedema peripheral
1%
Peripheral swelling
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

4Treatment groups
Experimental Treatment
Group I: Cohort 4: BrensocatibExperimental Treatment1 Intervention
Participants with severe hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Group II: Cohort 3: BrensocatibExperimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Group III: Cohort 2: BrensocatibExperimental Treatment1 Intervention
Participants with mild hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Group IV: Cohort 1: BrensocatibExperimental Treatment1 Intervention
Healthy participants with normal hepatic function will receive single oral dose of brensocatib on Day 1 under fasted conditions. Healthy participants will be matched within the protocol criteria to one or more participants with hepatic impairment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brensocatib
2023
Completed Phase 3
~620

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
41 Previous Clinical Trials
7,148 Total Patients Enrolled

Frequently Asked Questions

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

Has Brensocatib attained regulatory clearance from the FDA?

"Since this is a Phase 1 trial, only minimal data exists that suggests its safety and efficacy. As such, our team at Power assigned Brensocatib a score of one on the risk scale."

Answered by AI

Is there an opportunity for me to partake in this experiment?

"This clinical trial is currently seeking 30 participants with a history of hepatic impairment between the ages 18 and 70. For inclusion, each patient must meet specific criteria including a stable medication regimen, BMI between 18 and 35 kg/m^2, no episodes of illness within 30 days prior to screening or check-in that could alter their disease status as determined by medical history, laboratory evaluations, vital signs measurements, ECG tests and physical examinations administered by the investigator (or designee). Additionally these patients have to be adequately matched in terms of age (+/- 10 years), sex and BMI (+/- 20%) when compared to other subjects enrolled in this"

Answered by AI

Are there still open positions for participants in this experiment?

"The trial's recruitment status is currently in progress, per information on clinicaltrials.gov. The initial posting was made on October 4th 2022 and the latest update appeared November 7th of that year."

Answered by AI

How many participants have enrolled in this trial so far?

"The sponsor, Insmed Incorporated, is responsible for recruiting 30 patients that meet the study's criteria. These participants will be enrolled across two of the trial sites in Orlando and San Antonio respectively."

Answered by AI

Is it possible to partake in this investigation if one is above the age of 30?

"The study is open to patients aged 18-70, while there are 27 trials tailored for those below age of majority and 223 studies designed for people over 65."

Answered by AI
~12 spots leftby Mar 2025