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NCT07101640 · ClinicalTrials.gov registry record · Phase 1
PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
A Phase 1 study of Critical Illness and Bronchopulmonary Dysplasia (BPD), sponsored by Duke University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 4
- Study locations
NCT07101640: Recruiting Phase 1 study of Critical Illness and Bronchopulmonary Dysplasia (BPD), sponsored by Duke University.
NCT07101640 is a Phase 1 study of Critical Illness and Bronchopulmonary Dysplasia (BPD) that is actively recruiting participants, run by Duke University. The registered enrollment target is 28 participants, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07101640, a Phase 1 study of Critical Illness and Bronchopulmonary Dysplasia (BPD), is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the bloodstream, and how quickly it is removed from the bloodstream. Data supporting the prospect of montelukast benefit involved 6 previous studies involving 206 preterm infants. The dosing ranged from 0.5 to 2.5 mg/kg/day, which aligns with the proposed initial dose of 0.75 mg/kg/day. Though each previous study had a small population, collectively they reveal montelukast as a promising drug in populations of preterm infants developing BPD and for individual preterm infants who are "developing BPD." Thus, researchers expect clinical benefit for preterm infants in this study. Despite the benefit-to-risk ratio presented by these previous studies, the optimal dose remains to be determined; thus, this study design and PK analysis will start with the lowest dose that is likely to provide direct benefit to participants.
Primary Outcome
The elimination of montelukast divided by the concentration of montelukast.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG montelukast 4 mg granule
Study Locations (4)
North Carolina
- University of North Carolina (UNC) - Chapel Hill
- East Carolina University - Greenville
Arkansas
- Arkansas Children's Hospital - Little Rock
Nevada
- University Medical Center of Southern Nevada - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2026-02-23 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 1 |
What NCT07101640 shows while recruiting
NCT07101640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Critical Illness appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07101640 reports a single indexed study location in North Carolina, Arkansas, Nevada.
Frequently Asked Questions
What is clinical trial NCT07101640 about?
NCT07101640 is a clinical study titled "PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia". The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the bloodstream, and how quickly it is removed from the bloodstream. Data ...
What is the current status of trial NCT07101640?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2026-02-23. Estimated completion is 2028-05-31.
What conditions does trial NCT07101640 study?
This clinical trial studies the following conditions: Critical Illness, Bronchopulmonary Dysplasia (BPD), Premature Births.
What interventions are being tested in trial NCT07101640?
The interventions under investigation include: Placebo (DRUG), montelukast 4 mg granule (DRUG).
Who is sponsoring clinical trial NCT07101640?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07101640 being conducted?
This trial has 4 study locations across Arkansas, Nevada, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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