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NCT01086527 · ClinicalTrials.gov registry record · Phase 1
Genotype Stratified Pharmacokinetic Study of Montelukast
A Phase 1 study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01086527: Completed Phase 1 study, sponsored by Nemours Children's Clinic.
NCT01086527 is a Phase 1 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01086527, a Phase 1 study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Leukotriene receptor antagonists (LTRAs) are frequently prescribed to reduce the symptoms associated with asthma. Singulair (montelukast), manufactured by Merck, is a popular LTRA, however its effectiveness varies greatly between individuals. We are interested in understanding why the effectiveness of Singulair varies so greatly. For an oral drug such as Singulair to be effective, the body must efficiently absorb it. We have found that blood levels of Singulair vary greatly between individuals, and we think that this variability is responsible for variability in response. Drug absorption occurs primarily in the intestine. Due to differences in the chemical properties of drugs, some drugs can be absorbed easily while other drugs require help from special proteins produced by the cells that line the intestine. These proteins, or transporters act like revolving doors to allow drugs to move from the intestine to the bloodstream. The activity of a transporter can be influenced by individual genetic variability. We think that adsorption of Singulair requires help from a transport protein called OATP2B1. We have found that a single common genetic change in this protein is associated with low plasma concentration of montelukast. In this proposal we will determine plasma levels of montelukast in individuals with two copies of this genetic change. We predict that these individuals will have roughly half the plasma level of montelukast as individuals with no copies of this genetic change. Eventually, what we learn from this work will allow doctors to quickly test individuals with asthma to determine how well they will absorb Singulair and possibly other LTRAs. Knowing this will allow the doctor to adjust the drug treatment on an individual basis to maximize benefit in the treatment of asthma.
Primary Outcome
Area under the concentration vs. time curve for the plasma concentration of montelukast.
Interventions
- DRUG 10 mg tablet of montelukast (Singulair)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT01086527 record still lists
NCT01086527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which 10 mg tablet of montelukast (Singulair) is the first listed.
NCT01086527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01086527 about?
NCT01086527 is a clinical study titled "Genotype Stratified Pharmacokinetic Study of Montelukast". Leukotriene receptor antagonists (LTRAs) are frequently prescribed to reduce the symptoms associated with asthma. Singulair (montelukast), manufactured by Merck, is a popular LTRA, however its effectiveness varies greatly between individuals. We are interested in understanding why the effectiveness ...
What is the current status of trial NCT01086527?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2010-03. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01086527?
The interventions under investigation include: 10 mg tablet of montelukast (Singulair) (DRUG).
Who is sponsoring clinical trial NCT01086527?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01086527's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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