Skip to main content
OpenTrials
Completed

NCT Number: NCT05826574

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USA001

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brensocatib

Drug

Oral tablets.

Other names: INS1007

Rifampin

Drug

Oral capsules.

Esomeprazole

Drug

Oral capsules.

Primary outcomes

  1. Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 7, 17 (Part 1), and Days 1 to 7, 12 to 18 (Part 2)

    Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.

Secondary outcomes

  1. Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event (AE)

    Time frame: Up to Day 31 (Part 1) and up to Day 26 (Part 2)

    Safety and tolerability of brensocatib when administered alone and in combination with rifampin/esomeprazole will be determined in healthy participants.

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study title

A Phase 1, Open Label, Fixed Sequence Study to Assess the Pharmacokinetics of Brensocatib When Administered Alone and With Multiple Doses of Rifampin (CYP3A Inducer) or Esomeprazole (Proton Pump Inhibitor) in Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.