A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis

Inclusion Criteria

• Participants must be ≥18 years of age at the time of signing the informed consent.
• Male or female participants with a confirmed diagnosis of CF related lung disease:
• Percent predicted forced expiratory volume in 1 second (ppFEV1) between 40% to 90% (inclusive) at Screening Visit and at Baseline.
• Stable CF treatment for at least 30 days before screening and willing to remain on a stable regimen throughout the treatment period.
• Has a body mass index ≥18 kg/m^2.
• Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Male participants, who are not sterile, with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
• Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception methods (i.e., methods that alone or in combination achieve 480 millisecond (msec) at Screening.
• History of solid organ or hematological transplantation.
• Have diagnosed periodontal disease and are either:
• Currently treated by a dentist for this condition or
• Expected to have periodontal disease-related procedures within the study period.
• Received any live attenuated vaccine within 4 weeks prior Screening.
• Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 90 days prior to Screening.
• Known history of hypersensitivity to brensocatib or any of its excipients.
• Use of any immunomodulatory agents within 4 weeks before the Screening Visit is prohibited during the study through end of study (including, but not limited to: bortezomib, ixazomib, thalidomide, cyclophosphamide, mycophenolate, Janus kinase inhibitors, interferon gamma (IFN-γ], and azathioprine).
• Continuous use of high-dose non-steroidal anti-inflammatory drugs (NSAIDs) is prohibited during the study through end of study.
• History of alcohol, medication, or illicit drug abuse.
• Current smoker, as defined by Centers for Disease Control and Prevention: An adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes.