NCT05826574

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2023

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

April 12, 2023

Last Update Submit

August 17, 2023

Conditions

Healthy Volunteers

Keywords

BrensocatibINS1007

Outcome Measures

Primary Outcomes (1)

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

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

    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)

Secondary Outcomes (1)

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

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

Study Arms (4)

Part 1: Period 1: Brensocatib

EXPERIMENTAL

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

Drug: Brensocatib

Part 1: Period 2: Brensocatib + Rifampin

EXPERIMENTAL

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.

Drug: BrensocatibDrug: Rifampin

Part 2: Period 1: Brensocatib

EXPERIMENTAL

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

Drug: Brensocatib

Part 2: Period 2: Brensocatib + Esomeprazole

EXPERIMENTAL

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.

Drug: BrensocatibDrug: Esomeprazole

Interventions

BrensocatibDRUG

Oral tablets.

Also known as: INS1007
Part 1: Period 1: BrensocatibPart 1: Period 2: Brensocatib + RifampinPart 2: Period 1: BrensocatibPart 2: Period 2: Brensocatib + Esomeprazole
RifampinDRUG

Oral capsules.

Part 1: Period 2: Brensocatib + Rifampin
EsomeprazoleDRUG

Oral capsules.

Part 2: Period 2: Brensocatib + Esomeprazole

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy participants defined by no significant other conditions as in the protocol.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USA001

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

brensocatibRifampinEsomeprazole

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsOmeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingBenzimidazolesHeterocyclic Compounds, 2-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 24, 2023

Study Start

May 10, 2023

Primary Completion

July 16, 2023

Study Completion

July 16, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)