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Clinical trial

A Phase 1, Open Label, Fixed Sequence Study to Assess the Pharmacokinetics of Brensocatib When Administered Alone and With Multiple Doses of Rifampin (CYP3A Inducer) or Esomeprazole (Proton Pump Inhibitor) in Healthy Subjects

ID
Name
INS1007-106
Description
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.
Trial arms
Trial start
2023-05-10
Estimated PCD
2023-07-16
Trial end
2023-07-16
Status
Completed
Phase
Early phase I
Treatment
Brensocatib
Oral tablets.
Arms:
Part 1: Period 1: Brensocatib, Part 1: Period 2: Brensocatib + Rifampin, Part 2: Period 1: Brensocatib, Part 2: Period 2: Brensocatib + Esomeprazole
Other names:
INS1007
Rifampin
Oral capsules.
Arms:
Part 1: Period 2: Brensocatib + Rifampin
Esomeprazole
Oral capsules.
Arms:
Part 2: Period 2: Brensocatib + Esomeprazole
Size
32
Primary endpoint
Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma
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)
Eligibility criteria
Inclusion Criteria: * Healthy participants defined by no significant other conditions as in the protocol. Exclusion Criteria: * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immunological, oncologic, or psychiatric disorder, as determined by the investigator (or designee). * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee). Note: Other inclusion/exclusion criteria may apply.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}
Updated at
2023-08-21

1 organization

3 products

1 indication

Product
Brensocatib
Indication
Healthy Control Participants
Organization
Insmed
Product
Esomeprazole
Product
Rifampin