NCT04849650

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Acacia Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Disease, End Stage

Interventions

Type	Name	Description
DRUG	Amisulpride IV	A single 10mg IV dose of Amisulpride given over 1 minute
DRUG	Amisulpride Oral Tablet	A single 10mg dose given as an oral tablet

Timeline

• Start date: 2021-06-03
• Primary completion: 2021-10-30
• Completion: 2021-10-30
• First posted: 2021-04-19
• Last updated: 2021-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study