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

NCT04849650 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-12-13

No results posted yet for this study

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.

Conditions

  • Renal Disease, End Stage

Interventions

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

Sponsors & Collaborators

  • Acacia Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Gabriel Fox, MD · Chief Medical Officer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2021-10-30
Completion
2021-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849650 on ClinicalTrials.gov