A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants

Insmed

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Brensocatib; Drug: Rifampin; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT05826574

INS1007-106

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Part 1: Period 1: Brensocatib

Experimental group

Description:

Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 1 of the study.

Treatment:

Drug: Brensocatib

Part 1: Period 2: Brensocatib + Rifampin

Experimental group

Description:

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.

Treatment:

Drug: Rifampin

Drug: Brensocatib

Part 2: Period 1: Brensocatib

Experimental group

Description:

Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 2 of the study.

Treatment:

Drug: Brensocatib

Part 2: Period 2: Brensocatib + Esomeprazole

Experimental group

Description:

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.

Treatment:

Drug: Esomeprazole

Drug: Brensocatib