Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT04849650
Brief Summary:
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease. In addition it is important to understand how well tolerated Amisulpride is in this patient population. Healthy adults will be studied to provide a comparison.
Detailed Description:
This will be an open-label, non-randomised, pharmacokinetic study in
* 6 adult subjects with severe renal impairment and end-stage renal disease (i.e., eGFR \< 30 mL/min/1.73 m2) without dialysis.
* 6 matched healthy subjects (control group).
Each subject will be given a single dose of 10 mg IV Amisulpride, followed by a single dose of 10 mg oral Amisulpride given 24 hours later.
Subjects will be admitted to the clinic on Day -1. Dosing will start the following day (Day 1). Serial blood samples will be taken during Days 1-3 to assess the pharmacokinetics of Amisulpride. Subjects will remain in clinic over the duration of the study and will be discharged when the final blood sample is drawn on Day 3.
The tolerability /safety of Amisulpride will be assessed by clinical chemistry and haematology assessments, vital signs, electrocardiograms (ECG), physical examination and adverse event reporting.
Study:
NCT04849650
Study Brief:
Protocol Section:
NCT04849650