NCT03437265

A Pharmacokinetic Study of PLENVU® in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This study characterises the pharmacokinetic (PK) profile of the active ingredients of PLENVU (NER1006) and their related substances/metabolites. Subjects will receive PLENVU.

Detailed description

PLENVU is a novel, low volume (1 L) PEG 3350 and ascorbate based bowel preparation that has been developed to provide whole bowel cleansing. Studies have shown that formulating the osmotically active agents sodium ascorbate/ascorbic acid (also known as vitamin C) and sodium sulfate in combination with PEG 3350 enable a reduction in the volume of the PEG-based lavage solution. PLENVU has a dual formulation containing an initial majority PEG dose followed by a majority ascorbate dose to maximise the overall effectiveness. This novel formulation addresses the challenges faced by patients to comply with drinking higher volume, 2 and 3 L, preparations. The purpose of this study is to determine if there is systemic exposure to components of the PLENVU formulation (PEG 3350, ascorbate and potential related substances/metabolites (oxalic acid, glycolic acid, ethylene glycol and diethylene glycol).

Conditions

• Pharmacokinetic

Interventions

Type	Name	Description
DRUG	PLENVU powder for oral solution	PLENVU Dose 1 (1 sachet) and PLENVU Dose 2 (2 sachets)

Timeline

• Start date: 2020-09-03
• Primary completion: 2020-10-05
• Completion: 2020-10-05
• First posted: 2018-02-19
• Last updated: 2023-11-29
• Results posted: 2021-11-03

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study