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Safety, Tolerability and Pharmacokinetic (PK) of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib
NCT01844583 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to assess the drug-drug interaction (DDI) of either esomeprazole or rifampin on the single-dose PK of alisertib, and to complete an intensive QT study of single and multiple-dose alisertib.
Conditions Studied
Interventions
- DRUG Rifampin
- DRUG Esomeprazole
- DRUG Alisertib
Study Locations (7)
Texas
- — Dallas
- — San Antonio
Florida
- — Sarasota
Missouri
- — St Louis
Oklahoma
- — Oklahoma City
Tennessee
- — Nashville
Wisconsin
- — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2013-06-25 |
| Est. Completion | 2016-09-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01844583
The ClinicalTrials.gov registry entry for NCT01844583 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Millennium Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 3 interventions — of which Rifampin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01844583 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Texas, Florida, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01844583 about?
NCT01844583 is a clinical study titled "Safety, Tolerability and Pharmacokinetic (PK) of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib". The purpose of this study is to assess the drug-drug interaction (DDI) of either esomeprazole or rifampin on the single-dose PK of alisertib, and to complete an intensive QT study of single and multiple-dose alisertib.
What is the current status of trial NCT01844583?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2013-06-25. Estimated completion is 2016-09-06.
What conditions does trial NCT01844583 study?
This clinical trial studies the following conditions: Lymphoma, Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01844583?
The interventions under investigation include: Rifampin (DRUG), Esomeprazole (DRUG), Alisertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01844583?
This trial is sponsored by Millennium Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01844583 being conducted?
This trial has 7 study locations across Florida, Missouri, Oklahoma, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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