Ultrasonic evaluation of gallbladder emptying with ceruletide: comparison to oral cholecystography with fatty meal

Muraca, Maurizio; Cianci, Vito; Miconi, L.; Vilei, Maria Teresa

doi:10.1007/bf00203515

Cited by 4 publications

(3 citation statements)

References 19 publications

(37 reference statements)

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“…Some subjects remarked that they did not find the food cue appetizing, and this may have contributed in part to a lack of bile sample for a number of subjects. The food cue used in this study was applied 60 min prior to string withdrawal which has previously been determined to be sufficient time to allow maximal contraction of the gallbladder following ingestion of a fatty meal [21, 24]. Further work is being conducted to investigate whether other types of food cue would be more appropriate.…”

Section: Discussionmentioning

confidence: 99%

Use of Entero‐Test, a simple approach for non‐invasive clinical evaluation of the biliary disposition of drugs

Guiney

Beaumont

Thomas

et al. 2011

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THE SUBJECT• Biliary secretion is often a major route of elimination of drugs and metabolites. Knowledge of the biliary disposition of a drug in man is important in understanding the contribution of this route to overall clearance and the potential for drug-drug interactions which may have clinical consequences. • Current methods for collecting human bile as part of drug disposition studies are invasive and complex, requiring intubation of the duodenum. As a result, limited data exist regarding the biliary elimination of many drugs and their metabolites. WHAT THIS STUDY ADDS• This proof of utility study clearly demonstrates that bile samples for drug and metabolite analysis can be collected simply, safely and cost-effectively from subjects using non-invasive technology.• Using such technology, the biliary disposition of simvastatin was evaluated successfully in healthy subjects. Qualitative metabolite data compared favourably with reported biliary data derived from intubated patients dosed with radiolabelled simvastatin.• This technique has substantial utility for early clinical evaluation of biliary disposition of drugs. AIMTo evaluate the non-invasive collection of bile from healthy human subjects for the qualitative characterization of the biliary disposition of a drug, using spectrometric techniques. METHODSTwenty subjects underwent non-invasive bile capture using a peroral string test (Entero-Test) device prior to and following a single oral dose of simvastatin (80 mg). The device, consisting of a weighted gelatin capsule containing a highly absorbent nylon string, was swallowed by each subject with the proximal end of the string taped to the face. Once the weighted string was judged to have reached the duodenum, gallbladder contraction was stimulated in order to release bile. The string was then retrieved via the mouth, and bile samples were analysed for drug-related material using spectrometric and spectroscopic techniques following solvent extraction. RESULTSNumerous metabolites of simvastatin were detected, and the major metabolites were consistent with those reported from studies where bile was collected using invasive techniques from patients dosed with [ 14 C]-simvastatin. CONCLUSIONSThe results from this study demonstrate the utility of deploying the Entero-Test in human studies to provide structural information on biliary metabolites. This can be readily applied in drug development studies, including those in the target patient population and may eliminate the need for more invasive sampling techniques.

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Section: Discussionmentioning

confidence: 99%

Use of Entero‐Test, a simple approach for non‐invasive clinical evaluation of the biliary disposition of drugs

Guiney

Beaumont

Thomas

et al. 2011

Brit J Clinical Pharma

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“…UCC metabolite profiling may be potentially more translational as well. Although not noted for metabolism studies, UCC has been used in humans for diagnostic purposes …”

Section: Discussionmentioning

confidence: 99%

“…This method involves sampling bile from the gallbladder using a fine needle to aspirate a fixed amount of bile. Previously it has been used for diagnostic sampling of bile both clinically and in preclinical species . In the current paper we compare the biliary profile of ATV in dogs and monkeys sampled using UCC to the profiles obtained from bile duct‐cannulated (BDC) animals.…”

Section: Introductionmentioning

confidence: 99%

Application of ultrasound‐guided cholecystocentesis to the evaluation of the metabolite profiling in bile of dogs and cynomolgus monkeys

Dierks

Luk

Cai

et al. 2019

Pharmacology Res & Perspec

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In this study, we describe a novel approach for collecting bile from dogs and cynomolgus monkeys for metabolite profiling, ultrasound‐guided cholecystocentesis (UCC). Sampling bile by UCC twice within 24 hours was well tolerated by dogs and monkeys. In studies with atorvastatin (ATV) the metabolite profiles were similar in bile obtained through UCC and from bile duct‐cannulated (BDC) dogs. Similar results were observed in UCC and BDC monkeys as well. In both monkey and dog, the primary metabolic pathway observed for ATV was oxidative metabolism. The 2‐hydroxy‐ and 4‐hydroxyatorvastatin metabolites were the major oxidation products, which is consistent with previously published metabolite profiles. S‐cysteine and glucuronide conjugates were also observed. UCC offers a viable alternative to bile duct cannulation for collection of bile for metabolite profiling of compounds that undergo biliary excretion, given the similar metabolite profiles in bile obtained via each method. Use of UCC for metabolite profiling may reduce the need for studies using BDC animals, a resource‐intensive model.

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Ceruletide

2016

Meyler's Side Effects of Drugs

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Ultrasonic evaluation of gallbladder emptying with ceruletide: comparison to oral cholecystography with fatty meal

Cited by 4 publications

References 19 publications

Use of Entero‐Test, a simple approach for non‐invasive clinical evaluation of the biliary disposition of drugs

Use of Entero‐Test, a simple approach for non‐invasive clinical evaluation of the biliary disposition of drugs

Application of ultrasound‐guided cholecystocentesis to the evaluation of the metabolite profiling in bile of dogs and cynomolgus monkeys

Ceruletide

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