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NCT01409395 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Study With Metformin and Nizatidine
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01409395: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT01409395 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01409395, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will address the following question: Does nizatidine affect the pharmacokinetics of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated that nizatidine may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of metformin. The investigators hypothesize that the co-administration of metformin and nizatidine will reduce the renal clearance (CLR) of metformin leading to increased plasma concentrations and potential risk for toxicities. Knowledge of the pharmacokinetic interaction profile of metformin with organic transporter inhibitors, such as nizatidine, 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 Metformin and nizatidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01409395 record still lists
NCT01409395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT01409395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01409395 about?
NCT01409395 is a clinical study titled "Drug-Drug Interaction Study With Metformin and Nizatidine". This study will address the following question: Does nizatidine affect the pharmacokinetics of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated that nizatidine may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of...
What is the current status of trial NCT01409395?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2011-09. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01409395?
The interventions under investigation include: Metformin (DRUG), Metformin and nizatidine (DRUG).
Who is sponsoring clinical trial NCT01409395?
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 NCT01409395's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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