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Anti-inflammatory

A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment

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
No Placebo-Only Group

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Concentration Time Curve (AUC)
Secondary study objectives
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%
Dizziness
2%
Dyspepsia
2%
Nausea
2%
Hyperglycaemia
2%
Nervous system disorders
2%
Epistaxis
1%
Respiratory tract infection
1%
Tachyarrhythmia
1%
Glossodynia
1%
Fall
1%
Mouth ulceration
1%
Hypokalaemia
1%
Clostridium difficile colitis
1%
Pneumonia
1%
Dry mouth
1%
Palpitations
1%
Candida infection
1%
Sinus bradycardia
1%
Swollen tongue
1%
Pruritus
1%
Subcutaneous emphysema
1%
Hepatic function abnormal
1%
Constipation
1%
Bradycardia
1%
Headache
1%
Vomiting
1%
Gastritis erosive
1%
Dry skin
1%
Muscle spasms
1%
Gingival bleeding
1%
Gastrooesophageal reflux disease
1%
Alanine aminotransferase increased
1%
Glycosylated haemoglobin increased
1%
Paraesthesia
1%
Vision blurred
1%
Hypoaesthesia oral
1%
Lip pain
1%
Rash pruritic
1%
Acute kidney injury
1%
Arthralgia
1%
Urinary tract infection
1%
Staphylococcal bacteraemia
1%
Serratia infection
1%
Gastrointestinal disorders
1%
General disorders
1%
Skin disorders
1%
Chronic lymphocytic leukaemia
1%
Pulmonary embolism
1%
Vascular disorders
1%
Dyspnoea
1%
Rhinorrhoea
1%
Hallucination, visual
1%
Nightmare
1%
Liver function test abnormal
1%
Blood glucose abnormal
1%
Transaminases increased
1%
Acute coronary syndrome
1%
Supraventricular tachycardia
1%
Memory impairment
1%
Peripheral ischaemia
1%
Swelling face
1%
Extravasation
1%
Peripheral swelling
1%
Hiccups
1%
Pneumothorax
1%
Oedema peripheral
1%
Chest discomfort
1%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Brensocatib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
43 Previous Clinical Trials
7,551 Total Patients Enrolled
~9 spots leftby Dec 2025
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