About this trial
The primary objective of this study is to assess the effect of multiple doses of brensocatib on the single dose PK of oral midazolam when coadministered in healthy male and female participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m²).
Normal renal function as determined by estimated glomerular filtration rate and calculated using the Chronic Kidney Disease Epidemiology Collaboration formula.
Resting blood pressure of 90 to 140 milligrams of mercury (mmHg) (systolic) and 40 to 90 mmHg (diastolic).
Judged by the Investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings.
Disqualifiers
History or clinical manifestations of a significant neurological, cardiovascular, gastrointestinal, pulmonary, hematologic, immunologic, oncologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
History of relevant drug and/or food allergies (i.e., allergy to brensocatib or midazolam or any excipients, or any significant food allergy).
Positive drug and/or alcohol screen (opiates, methadone, cocaine, amphetamines, methamphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and/or at admission to the clinical site.
Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus 1 and 2 antibodies at screening. A positive result for HCV antibodies will be allowed, if the participant has documented proof of prior, successful treatment.
Trial design
Single group
Treatments tested in this trial
Brensocatib
DrugOral tablets
Midazolam
DrugOral solution
Treatment groups
Trial outcomes
Primary outcomes
Plasma Concentration of Midazolam and its Metabolite
Secondary outcomes
Number of Participants Who Experienced At Least One Adverse Event (AE)
Plasma Concentration of Brensocatib
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: