A Phase 1 interventional study of Brensocatib and Rifampin in Healthy Volunteers, sponsored by Insmed Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Insmed Incorporated · Phase 1, Interventional, and Treatment
The primary purpose of this study is to assess the effects of rifampin on the PK of brensocatib in Part 1 of the study and to assess the effects of esomeprazole on the PK of brensocatib in Part 2 of the study.
Insmed Incorporated is the lead sponsor of 50 studies on the registry; 8 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 8 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note: Other inclusion/exclusion criteria may apply.
Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 1 of the study.
Drug: Brensocatib
Period 2: Participants will receive rifampin 600 mg once daily (QD), orally, on Days 8 to 23 along with a single oral dose of brensocatib prior to the rifampin administration on Day 17 in Part 1 of the study.
Drug: Brensocatib · Drug: Rifampin
Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 2 of the study.
Drug: Brensocatib
Period 2: Participants will receive esomeprazole 40 mg QD, orally, on Days 8 to 12 along with a single oral dose of brensocatib prior to the esomeprazole administration on Day 12 in Part 2 of the study.
Drug: Brensocatib · Drug: Esomeprazole
Oral tablets.
Also known as: INS1007
Oral capsules.
Oral capsules.
Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma
Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 7, 17 (Part 1), and Days 1 to 7, 12 to 18 (Part 2)
Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event (AE)
Safety and tolerability of brensocatib when administered alone and in combination with rifampin/esomeprazole will be determined in healthy participants.
Time frame: Up to Day 31 (Part 1) and up to Day 26 (Part 2)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Insmed Incorporated