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NCT01318265 · ClinicalTrials.gov registry record · Phase 1
Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics
A Phase 1 study of Pharmacokinetics, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01318265: Completed Phase 1 study of Pharmacokinetics, sponsored by Bayer.
NCT01318265 is a Phase 1 study of Pharmacokinetics that has completed, run by Bayer. The registered enrollment target is 24 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01318265, a Phase 1 study of Pharmacokinetics, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.
Conditions Studied
Interventions
- DRUG Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole
Study Locations (1)
Massachusetts
- - Brighton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT01318265 record still lists
NCT01318265 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 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Pharmacokinetics appearing as the primary indexed condition, and to 1 intervention - of which Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole is the first listed.
NCT01318265 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01318265 about?
NCT01318265 is a clinical study titled "Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics". The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.
What is the current status of trial NCT01318265?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-03. Estimated completion is 2011-07.
What conditions does trial NCT01318265 study?
This clinical trial studies the following conditions: Pharmacokinetics.
What interventions are being tested in trial NCT01318265?
The interventions under investigation include: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole (DRUG).
Who is sponsoring clinical trial NCT01318265?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01318265 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pharmacokinetics
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01318265's enrollment target sits among peer trials
24 23rd of 37 higher than 12 of 37 other Pharmacokinetics trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pharmacokinetics 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.
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