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Clinical Trial Details

Trial ID: L0778
Source ID: NCT04849650
Associated Drug: Amisulpride Iv
Title: PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Renal Disease, End Stage
Interventions: DRUG: Amisulpride IV|DRUG: Amisulpride Oral Tablet
Outcome Measures: Primary: PK: Amisulpride plasma exposure (AUC) after a single IV dose, Amisulpride plasma exposure after a single IV dose measured as the area under the concentration-time curve (AUC) between study drug administration and the time at which the following-day oral dose of Amisulpride is given, 24 hours | Secondary: PK: Amisulpride plasma exposure (AUC) after a single oral dose, Amisulpride plasma exposure after a single oral dose measured as the area under the concentration-time curve (AUC) from study drug administration extrapolated to infinity, 24 hours|PK: Cmax, Peak plasma concentration (Cmax), for both a single IV and single oral dose., 24 hours|PK: Tmax, Time at which peak plasma concentration achieved (Tmax) for both a single IV and single oral dose., 24 hours|PK: T1/2, Half-life (T1⁄2) of both a single IV and single oral dose., 24 hours|PK: Clearance, Clearance of both a single IV and single oral dose., 24 hours|PK: Vd, Volume of distribution (Vd) of both a single IV and single oral dose., 24 hours|Safety: AE, Frequency and severity of treatment-emergent adverse events, From first study drug administration until discharge (4 days)
Sponsor/Collaborators: Sponsor: Acacia Pharma Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2021-06-03
Completion Date: 2021-10-30
Results First Posted:
Last Update Posted: 2021-12-13
Locations: Panax Clinical Research, Miami Lakes, Florida, 33014, United States
URL: https://clinicaltrials.gov/show/NCT04849650