Renal Disease, End StagePhase 1NCT04849650

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

A Phase 1 study testing Amisulpride IV and Amisulpride Oral Tablet in people with Renal Disease, End Stage, run by Acacia Pharma Ltd at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Renal Disease, End Stage
What is being tested?: Amisulpride IV and Amisulpride Oral Tablet
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 3 Jun 2021to 30 Oct 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:

Show all 18Show fewer

The absence of clinically significant illness and surgery within 4 weeks prior to dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Principal Investigator;
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.
Must agree to use an adequate method of contraception
A diagnosis of renal impairment that has been stable, without significant change in overall disease status in the 3 months prior to screening as determined by the Principal Investigator, with no requirement for dialysis, and an eGFR at screening < 30 mL/min/1.73 m2 calculated using the MDRD4 equation.

Who cannot join

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.

Show all 45Show fewer

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.
History of clinically significant arrhythmias or ischaemic heart disease (especially ventricular arrhythmias, atrial fibrillation (AF), recent conversion from AF or coronary spasm).
Conditions predisposing the volunteer to electrolyte imbalances (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa).
Clinically significant abnormal biochemistry,haematology or urinalysis at screening as judged by the investigator
Positive drugs of abuse test result
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results at screening.
Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening or menses) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the dosing.
Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 2,000 mg per day acetaminophen) or herbal remedies in the 14 days before IMP administration
Administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
Failure to satisfy the investigator of fitness to participate for any other reason.
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 to screening.
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.
History of clinically significant arrhythmias or unstable ischaemic heart disease (especially ventricular arrhythmias, atrial fibrillation (AF), recent conversion from AF or coronary spasm).
Positive drugs of abuse test result, unless caused by a documented prescription drug.
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results at screening.
Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening or menses) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the dosing.
Administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
Failure to satisfy the investigator of fitness to participate for any other reason.

Trial locations and contacts

1 site in 1 country.

United States1 site

Panax Clinical Research
Miami Lakes, Florida, 33014

Other trials in United States

About this study

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

Read the 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
Being tested: Amisulpride IV, Amisulpride Oral Tablet
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Amisulpride IVDrug
A single 10mg IV dose of Amisulpride given over 1 minute
Amisulpride Oral TabletDrug
A single 10mg dose given as an oral tablet

Study groups in NCT04849650
Study group	Role	What they receive
Renal Impairment Subjects	Experimental	10mg dose of IV Amisulpride, followed 24 hours by a 10mg oral dose of Amisulpride Receives: 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 Receives: Drug: Amisulpride IV; Drug: Amisulpride Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 24 hours

Secondary outcomes (7)

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
Measured: 24 hours
PK: Cmax
Peak plasma concentration (Cmax), for both a single IV and single oral dose.
Measured: 24 hours
PK: Tmax
Time at which peak plasma concentration achieved (Tmax) for both a single IV and single oral dose.
Measured: 24 hours
PK: T1/2
Half-life (T1⁄2) of both a single IV and single oral dose.
Measured: 24 hours
PK: Clearance
Clearance of both a single IV and single oral dose.
Measured: 24 hours
PK: Vd
Volume of distribution (Vd) of both a single IV and single oral dose.
Measured: 24 hours
Safety: AE
Frequency and severity of treatment-emergent adverse events
Measured: From first study drug administration until discharge (4 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 202130 Oct 2021

First posted19 Apr 2021
Study start3 Jun 2021
Primary completion30 Oct 2021
Study completion30 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal Disease, End StageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04849650
Sponsor's protocol ID: DP10026
Status last verified: Dec 2021
First submitted: 14 Apr 2021
Last updated: 13 Dec 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Disease, End Stage trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study of the Pharmacokinetics of Intravenous and Oral Amisulpride in Adults With Severe Renal Impairment and Healthy Control Subjects
ClinicalTrials.gov ID: NCT04849650
Acronym / sponsor ID: DP10026
Conditions: Renal Disease, End Stage
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Acacia Pharma LtdIndustry (pharma, biotech, devices)
Study start: 3 Jun 2021 (actual)
Primary completion: 30 Oct 2021 (actual)
Study completion: 30 Oct 2021 (actual)
First posted: 19 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

The tolerability /safety of Amisulpride will be assessed by clinical chemistry and haematology assessments, vital signs, electrocardiograms (ECG), physical examination and adverse event reporting.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Renal Impairment Subjects	Experimental	Drug: Amisulpride IV, Drug: Amisulpride Oral Tablet10mg dose of IV Amisulpride, followed 24 hours by a 10mg oral dose of Amisulpride
Healthy Subjects	Experimental	Drug: Amisulpride IV, Drug: Amisulpride Oral Tablet10mg dose of IV Amisulpride, followed 24 hours by a 10mg oral dose of Amisulpride

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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

Key exclusion criteria (45 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amisulpride IVA single 10mg IV dose of Amisulpride given over 1 minute	Drug	Healthy Subjects, Renal Impairment Subjects
Amisulpride Oral TabletA single 10mg dose given as an oral tablet	Drug	Healthy Subjects, Renal Impairment Subjects

Primary outcome

PK: Amisulpride plasma exposure (AUC) after a single IV dose
Time frame: 24 hours
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

7 secondary outcomes

PK: Amisulpride plasma exposure (AUC) after a single oral dose
Time frame: 24 hours
PK: Cmax
Time frame: 24 hours
PK: Tmax
Time frame: 24 hours
PK: T1/2
Time frame: 24 hours
PK: Clearance
Time frame: 24 hours
PK: Vd
Time frame: 24 hours
Safety: AE
Time frame: From first study drug administration until discharge (4 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
Individual participant dataSharing planned: No

Related trials for Renal Disease, End Stage

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gabriel Fox, MD study director

Chief Medical Officer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Amisulpride IV and Amisulpride Oral Tablet in people with Renal Disease, End Stage, run by Acacia Pharma Ltd at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK: Amisulpride plasma exposure (AUC) after a single IV dose (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04849650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.