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NCT00258050 · ClinicalTrials.gov registry record · Phase 1
To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00258050: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT00258050 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00258050, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics of a single oral and single intravenous dose of midazolam in adult cancer patients. Also to assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.
Primary Outcome
Blood samples will be collected at indicated time points for the determination of midazolam concentration. AUC of midazolam in the presence and absence of lapatinib will be determined.
Interventions
- DRUG Midazolam
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2005-11-21 |
| Est. Completion | 2007-02-08 |
| Phase | Phase 1 |
What the finished NCT00258050 record still lists
NCT00258050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT00258050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00258050 about?
NCT00258050 is a clinical study titled "To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients". To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics of a single oral and single intravenous dose of midazolam in adult cancer patients. Also to assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.
What is the current status of trial NCT00258050?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2005-11-21. Estimated completion is 2007-02-08.
What interventions are being tested in trial NCT00258050?
The interventions under investigation include: Midazolam (DRUG), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT00258050?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00258050's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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