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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2023-07-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants

NCT05965570

Healthy Volunteers

COMPLETED PHASE1

Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects

NCT04606537

Healthy Drug Drug Interaction

COMPLETED PHASE1

Drug-drug Interaction Study of XZP-3621 Tablet

NCT05586568

Healthy Subjects

UNKNOWN PHASE1

A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects

NCT05928988

Healthy

COMPLETED PHASE1

A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants

NCT06170723

Healthy Participants

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1: Period 1: Brensocatib

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

Group Type EXPERIMENTAL

Brensocatib

Intervention Type DRUG

Oral tablets.

Part 1: Period 2: Brensocatib + Rifampin

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.

Group Type EXPERIMENTAL

Brensocatib

Intervention Type DRUG

Oral tablets.

Rifampin

Intervention Type DRUG

Oral capsules.

Part 2: Period 1: Brensocatib

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

Group Type EXPERIMENTAL

Brensocatib

Intervention Type DRUG

Oral tablets.

Part 2: Period 2: Brensocatib + Esomeprazole

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.

Group Type EXPERIMENTAL

Brensocatib

Intervention Type DRUG

Oral tablets.

Esomeprazole

Intervention Type DRUG

Oral capsules.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brensocatib

Oral tablets.

Intervention Type DRUG

Rifampin

Oral capsules.

Intervention Type DRUG

Esomeprazole

Oral capsules.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

INS1007

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes