PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment

Renal Disease, End Stage Clinical Trial

Official title: An Open Label Study of the Pharmacokinetics of Intravenous and Oral Amisulpride in Adults With Severe Renal Impairment and Healthy Control Subjects

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Disease, End Stage

• NCT number: NCT04849650
• Study type: Interventional
• Source: Acacia Pharma Ltd
• Status: Completed
• Phase: Phase 1
• Start date: June 3, 2021
• Completion date: October 30, 2021