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Anti-inflammatory

Cohort 2 (Moderate Impairment): Brensocatib for Kidney Failure

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 14
Awards & highlights

Study Summary

The primary purpose of the study is to determine the pharmacokinetics (PK) following a single oral dose administration of brensocatib, safety, and tolerability of brensocatib when administered to participants with impaired renal function and in healthy participants.

Eligible Conditions
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and at multiple timepoints post-dose on days 1 to 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and at multiple timepoints post-dose on days 1 to 14 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 Plasma Concentration Time Curve (AUC) of Brensocatib
Maximum Observed Plasma Concentration (Cmax) of Brensocatib
Number of Participants who Experienced at Least one Adverse Event (AE)
+1 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%
Gastrooesophageal reflux disease
1%
Peripheral swelling
1%
Glossodynia
1%
Oedema peripheral
1%
Pruritus
1%
Extravasation
1%
Hepatic function abnormal
1%
Swollen tongue
1%
Dyspnoea
1%
Supraventricular tachycardia
1%
Vomiting
1%
Constipation
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 (Normal): BrensocatibExperimental Treatment1 Intervention
Healthy participants with normal renal 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 renal impairment.
Group II: Cohort 3 (Severe Impairment): BrensocatibExperimental Treatment1 Intervention
Participants with severe renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Group III: Cohort 2 (Moderate Impairment): BrensocatibExperimental Treatment1 Intervention
Participants with moderate renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Group IV: Cohort 1 (Mild Impairment): BrensocatibExperimental Treatment1 Intervention
Participants with mild renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brensocatib
2023
Completed Phase 3
~620

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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
7,174 Total Patients Enrolled
~7 spots leftby Jun 2025
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