At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
In Brief
A Phase 4 clinical trial evaluating pravastatin and chenodeoxycholic acid, after metformin and placebo and valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo for Bile Salt Export Pump (BSEP) Transporter and Polysorbate 80. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg
single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg