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

NCT04849650 | Completed Phase 1 FDA Drug

• 1 other identifier: DP10026
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Disease, End Stage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• PK: Amisulpride plasma exposure (AUC) after a single oral dose

  24 hours

• PK: Cmax

  24 hours

• PK: Tmax

  24 hours

• PK: T1/2

  24 hours

• PK: Clearance

  24 hours

Study Arms (2)

Renal Impairment Subjects

EXPERIMENTAL

10mg dose of IV Amisulpride, followed 24 hours by a 10mg oral dose of Amisulpride

Drug: Amisulpride IV; Drug: Amisulpride Oral Tablet

Healthy Subjects

EXPERIMENTAL

10mg dose of IV Amisulpride, followed 24 hours by a 10mg oral dose of Amisulpride

Drug: Amisulpride IV; Drug: Amisulpride Oral Tablet

Interventions

Amisulpride IV DRUG

A single 10mg IV dose of Amisulpride given over 1 minute

Healthy Subjects; Renal Impairment Subjects

Amisulpride Oral Tablet DRUG

A single 10mg dose given as an oral tablet

Healthy Subjects; Renal Impairment Subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years of age at time of signing ICF.
• Body mass index (BMI) between 18 and 38 kg/m2.
• Must be willing and able to communicate and participate in the whole study.
• Must provide written informed consent.
• Must agree to use an adequate method of contraception
• Healthy as defined by:
• The absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic (including cholecystectomy), and metabolic disease;
• The absence of clinically significant history of lactic acidosis and severe hepatomegaly with steatosis;
• The absence of history of suicidal tendency, disposition to seizures, state of confusion, or clinically relevant psychiatric diseases.
• Normal renal function, i.e., eGFR or creatinine clearance ≥ 90 mL/min/1.73 m2 as calculated using the MDRD4 or Cockcroft-Gault equation; at the Principal Investigator's discretion, 24 hour creatinine clearance may be conducted to determine renal function.
• Matched to subjects with severe renal impairment for gender, age (± 10 years), and BMI (± 15%) to the extent possible.
• Age 18 to 75 years of age at time of signing ICF.
• Body mass index (BMI) between 18 and 38 kg/m2.
• Must be willing and able to communicate and participate in the whole study.
• Must provide written informed consent.

You may not qualify if:

• Subjects who have received any IMP in a clinical research study within the 30 days prior to IMP administration on this study.
• Subjects who are study site, CRO or sponsor employees, or immediate family members of a study site, CRO or sponsor employee.
• Subjects who have previously been enrolled in this study.
• Women who are pregnant or breastfeeding.
• Subjects who have received amisulpride for any indication within the 30 days prior to dosing.
• Allergy to amisulpride or any of the excipients of amisulpride.
• History of any drug or alcohol abuse in the 2 years prior to screening.
• Regular alcohol consumption \>21 units per week in the 6 months prior to screening.
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening.
• History of epilepsy in the 5years prior toscreening.
• History of clinically significant syncope.
• Family history of sudden death.
• Family history of premature cardiovascular death.
• Clinically significant history or family history of congenital long QT syndrome (e.g.
• Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's syndrome.

Sponsors & Collaborators

• Acacia Pharma Ltd: lead

Study Sites (1)

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Gabriel Fox, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: All parties will have knowledge of the interventions assigned to each subject.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One group of subjects with renal impairment will receive 10mg IV Amisulpride followed 24 hours later by a 10mg oral dose. One group of matched healthy subjects will receive 10mg IV Amisulpride followed 24 hours later by a 10mg oral dose.

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 19, 2021
• Study Start: June 3, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)