Skip to main content
OpenTrials
Completed

NCT Number: NCT05355935

A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USA001

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) between 18.0 and 32.0 kilogram per square metre (kg/m^2), inclusive, and a total body weight greater than or equal to 50 kilograms (kg)
  • Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
  • Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions
  • Able to swallow tablets

Exclusion criteria

  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee)
  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
  • QTcF interval >430 ms for males and >440 ms for females or QRS >120 ms
  • A history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, or family history of long QT syndrome)
  • Positive serology test results for hepatitis B panel and hepatitis C antibody and/or reactive human immunodeficiency virus 1/2 test
  • Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 14 days prior to dosing
  • Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee)
  • Use or intend to use any prescription medications/products within 14 days prior to dosing, unless deemed acceptable by the investigator (or designee)
  • Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee)
  • Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee)
  • Use or intend to use any medications that may increase QT interval within 14 days prior to check-in
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing
  • Have previously completed or withdrawn from this study or any other study investigating brensocatib, and have previously received brensocatib
  • Alcohol consumption of >14 units per week for males and >7 units for females. One unit of alcohol equals 12 ounce (oz) (360 milliliter [mL]) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine
  • Consumption of caffeine-containing products within 48 hours prior to check-in, unless deemed acceptable by the investigator (or designee)
  • History of chemical abuse, illicit substance, or marijuana use within 1 year prior to check-in
  • Use of tobacco- or nicotine-containing products within 3 months prior to check-in
  • Receipt of blood products within 2 months prior to check-in
  • Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening
  • Poor peripheral venous access

Treatment and study plan

Brensocatib

Drug

Oral tablet.

Other names: INS1007

moxifloxacin

Drug

Oral tablet.

Placebo

Drug

Oral tablet.

Primary outcomes

  1. 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)

    Time frame: Up to Day 7

  2. Part 2: Placebo- and Baseline-Corrected QTcF (ΔΔQTcF)

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

Secondary outcomes

  1. Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Brensocatib

    Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  2. Parts 1 and 2: Time to Maximum Observed Plasma Concentration (Tmax) of Brensocatib

    Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  3. Parts 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUCtlast) of Brensocatib

    Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  4. Parts 1 and 2: AUC From Time Zero Extrapolated to Infinity (AUC∞) of Brensocatib

    Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  5. Parts 1 and 2: Elimination Half-Life (t1/2) of Brensocatib

    Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  6. Parts 1 and 2: Total Clearance of Brensocatib Following Extravascular Administration (CL/F)

    Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  7. Parts 1 and 2: Volume of Distribution of Brensocatib Following Extravascular Administration (Vz/F)

    Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  8. Parts 2: Change From Baseline in QTcF (ΔQTcF) Interval

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  9. Part 2: Number of Participants With Categorical Outliers for ECG Parameters: HR, PR, QRS, and QTcF

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  10. Part 2: Number of Participants who Experienced at least one TEAE

    Time frame: 7 days after the last dose (up to 35 days)

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study title

A Two-part, Phase I, Double-blind, Placebo- and Positive-controlled Crossover Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 2, 2022
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.