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NCT01404715 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Study With Metformin and Imatinib
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT01404715: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT01404715 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01404715, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This study will address the following question: Does imatinib influence the pharmacokinetics of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated that imatinib may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of metformin. 1. The investigators hypothesize that the addition of imatinib to metformin therapy will reduce the renal clearance (CLR) of metformin leading to increased plasma concentrations and risk for toxicities 2. Knowledge of the pharmacokinetic interaction profile of metformin with organic cation transporter inhibitors, such as imatinib, is important to help develop safer more effective drug therapy with reduced side effects.
Primary Outcome
Cmax and Tmax will be determined from AUC-time curve Glomerular filtration rate (GFR) will be approximated by measured creatinine clearance using the following equation:GFR calculation: GFR = CLcreatinine = (Urinary creatinine \* V) / (Plasma creatinine)
Interventions
- DRUG Metformin
- DRUG Imatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01404715 record still lists
NCT01404715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT01404715 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01404715 about?
NCT01404715 is a clinical study titled "Drug-drug Interaction Study With Metformin and Imatinib". This study will address the following question: Does imatinib influence the pharmacokinetics of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated that imatinib may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of ...
What is the current status of trial NCT01404715?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2011-10. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01404715?
The interventions under investigation include: Metformin (DRUG), Imatinib (DRUG).
Who is sponsoring clinical trial NCT01404715?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01404715's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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