Brensocatib
DrugOral tablet
Other names: INS1007
NCT Number: NCT05673603
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 1
USA002, Orlando, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
(for Participants With Renal Impairment):
Inclusion criteria
for Healthy Participants:
Exclusion criteria
Exclusion criteria
(for Participants With Renal Impairment):
Exclusion criteria
(for Healthy Participants):
Note: Other inclusion/exclusion criteria may apply.
Oral tablet
Other names: INS1007
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Pharmacokinetics of brensocatib following a single dose will be assessed in participants with renal impairment and in healthy participants.
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Time frame: Up to Day 14
Determination of the safety and tolerability of a single dose of brensocatib in participants with impaired renal function and in healthy participants.
Insmed Incorporated
Industry
A Phase 1, Open-Label, Single Dose Parallel-Group Study of Brensocatib Following a Single Oral Administration in Subjects With or Without Renal Impairment
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.
NCT03896750
Actinomycetales Infections, Bacterial Infections
Miami, Florida, United States
View Trial DetailsNCT03289208
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Tokyo, Japan
View Trial DetailsNCT07217886
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Orlando, Florida, United States
View Trial DetailsNCT06671444
Dyssomnias, Female Urogenital Diseases
Nanjing, Jiangsu, China
View Trial Details