A Study to Assess the Potential CYP3A Induction Effect of Brensocatib on the Pharmacokinetics (PK) of Midazolam in Healthy Participants

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorInsmed Incorporated

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Brensocatib

    Drug

    Oral tablets

  • Midazolam

    Drug

    Oral solution

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Midazolam + BrensocatibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Plasma Concentration of Midazolam and its Metabolite

Time frame
Pre-dose and at multiple timepoints post-dose (up to Day 15)

Secondary outcomes

1

Number of Participants Who Experienced At Least One Adverse Event (AE)

Time frame
Up to day 21
2

Plasma Concentration of Brensocatib

Time frame
Pre-dose and at multiple timepoints post-dose up to Day 15

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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