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NCT01205230 · ClinicalTrials.gov registry record · Phase 4
VEG113971: An Open-Label Study of the Effects of Ketoconazole or Esomeprazole on Pazopanib PK
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
NCT01205230: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01205230 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01205230, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to determine how dosing with ketoconazole (Nizoral) or esomeprazole (Nexium) affects the pharmacokinetics of oral pazopanib. The study will also test for safety of pazopanib when administered with ketoconazole or esomeprazole.
Primary Outcome
Blood samples for pharmacokinetic (PK) analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter AUC(0-24) was determined by standard non-compartmental analysis using WinNonlin. Plasma AUC(0-24) is a measure of the amount of drug a participant has been exposed to in 24 hours.
Interventions
- DRUG pazopanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-08 |
| Phase | Phase 4 |
What the finished NCT01205230 record still lists
NCT01205230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which pazopanib is the first listed.
NCT01205230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01205230 about?
NCT01205230 is a clinical study titled "VEG113971: An Open-Label Study of the Effects of Ketoconazole or Esomeprazole on Pazopanib PK". The purpose of this study is to determine how dosing with ketoconazole (Nizoral) or esomeprazole (Nexium) affects the pharmacokinetics of oral pazopanib. The study will also test for safety of pazopanib when administered with ketoconazole or esomeprazole.
What is the current status of trial NCT01205230?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2010-09. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01205230?
The interventions under investigation include: pazopanib (DRUG).
Who is sponsoring clinical trial NCT01205230?
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 NCT01205230's enrollment target sits among peer trials
34 1520th of 2000 higher than 473 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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