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NCT04640571 · ClinicalTrials.gov registry record · Phase 4
Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
A Phase 4 study of Bile Salt Export Pump (BSEP) Transporter and Polysorbate 80, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04640571: Completed Phase 4 study of Bile Salt Export Pump (BSEP) Transporter and Polysorbate 80, sponsored by University of Maryland, Baltimore.
NCT04640571 is a Phase 4 study of Bile Salt Export Pump (BSEP) Transporter and Polysorbate 80 that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 18 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04640571, a Phase 4 study of Bile Salt Export Pump (BSEP) Transporter and Polysorbate 80, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The study employs two-sub-studies that share a common placebo arm. The objective of one sub-study is to assess the impact of metformin on pravastatin and chenodeoxycholic acid pharmacokinetics. We hypothesize that metformin represses the bile salt export pump (BSEP) in the liver, which excretes pravastatin and chenodeoxycholic acid from the liver into the bile. The objective of the other sub-study is to assess the impact of polysorbate 80 on valacyclovir, chenodeoxycholic acid, and enalaprilat pharmacokinetics. We hypothesize that polysorbate 80 inhibits uptake transporters in the intestine, which absorb valacyclovir and chenodeoxycholic acid in the gut via the peptide transporter 1 (PepT1) and apical sodium-bile acid transporter (ASBT), respectively. Enalaprilat is passively absorbed but with low permeability, and thus serves as a passive absorption reference.
Primary Outcome
Pravastatin AUC after metformin, compared to pravastatin AUC after placebo. AUC units are concentration x time (i.e. ng/ml x h).
Conditions Studied
Interventions
- DRUG pravastatin and chenodeoxycholic acid, after metformin and placebo
- DRUG valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo
Study Locations (1)
Maryland
- University of Maryland - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2021-11-01 |
| Phase | Phase 4 |
What the finished NCT04640571 record still lists
NCT04640571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Bile Salt Export Pump (BSEP) Transporter appearing as the primary indexed condition, and to 2 interventions - of which pravastatin and chenodeoxycholic acid, after metformin and placebo is the first listed.
NCT04640571 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04640571 about?
NCT04640571 is a clinical study titled "Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition". The study employs two-sub-studies that share a common placebo arm. The objective of one sub-study is to assess the impact of metformin on pravastatin and chenodeoxycholic acid pharmacokinetics. We hypothesize that metformin represses the bile salt export pump (BSEP) in the liver, which excretes pra...
What is the current status of trial NCT04640571?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2021-04-01. Estimated completion is 2021-11-01.
What conditions does trial NCT04640571 study?
This clinical trial studies the following conditions: Bile Salt Export Pump (BSEP) Transporter, Polysorbate 80.
What interventions are being tested in trial NCT04640571?
The interventions under investigation include: pravastatin and chenodeoxycholic acid, after metformin and placebo (DRUG), valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo (DRUG).
Who is sponsoring clinical trial NCT04640571?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04640571 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04640571's enrollment target sits among peer trials
18 1842nd of 2000 higher than 147 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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