Status:
COMPLETED
A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Participants
Lead Sponsor:
Insmed Incorporated
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05355935
Start Date
April 27 2022
End Date
October 7 2022
Last Update
March 27 2023
Active Locations (1)
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1
USA001
Madison, Wisconsin, United States, 53704