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Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856

Primary Purpose

Cognition Disorder, Alzheimer Disease

Status
Completed
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
ACD856
Sponsored by
AlzeCure Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognition Disorder focused on measuring Cognition Disorder, Alzheimer's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy males aged >18 and <65 years. Signed and dated informed consent prior to any study-mandated procedure Willing and able to comply with study requirements. BMI >18.0 and <30.0 kg/m^2 Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP. Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator. Exclusion Criteria: History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. Any planned major surgery within the duration of the study. Clinically relevant findings in laboratory parameters, ECG or vital signs at screening History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity Regular use of any prescribed or non-prescribed medication Planned treatment or treatment with another investigational drug within 3 months Current smokers or users of nicotine products. Positive screen for drugs of abuse or alcohol at screening History of alcohol abuse or excessive intake of alcohol Presence or history of drug abuse History of, or current use of, anabolic steroids. Excessive caffeine consumption Plasma donation within one month of screening or blood donation during the 3 months prior to screening.

Sites / Locations

  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ACD856

Arm Description

Outcomes

Primary Outcome Measures

Area under the plasma concentration vs time curve from time zero extrapolated to infinity
a pharmacokinetic measure of the amount of study medication present in the blood
AUC from time zero to time of last quantifiable analyte concentration
a pharmacokinetic measure of the amount of study medication present in the blood
Half-life associated with terminal slope of a semi-logarithmic concentration-time curve
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
Total body clearance following iv administration
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
Volume of distribution following iv administration
a theoretical estimate of how much of the study drug that the body may contain

Secondary Outcome Measures

Number of subjects with adverse events
how many participants have reported a drug related advers event
Number of subjects with clinically significant changes in vital signs
how many participants have had any clinically significant changes in vital signs
Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs)
how many participants have had study drug related changes to cardiac function
Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis
how many participants have had study drug related changes in laboratory test analyses

Full Information

First Posted
April 1, 2021
Last Updated
March 23, 2023
Sponsor
AlzeCure Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05783830
Brief Title
Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856
Official Title
A Phase 0, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics of a Single Intravenous Microdose of ACD856 in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
April 18, 2020 (Actual)
Study Completion Date
April 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AlzeCure Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a Phase 0, open-label, non-controlled, single-centre study designed to evaluate the pharmacokinetics (PK) and safety and tolerability of a single, bolus intravenous (iv) injection of a microdose of ACD856 in healthy subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition Disorder, Alzheimer Disease
Keywords
Cognition Disorder, Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACD856
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ACD856
Intervention Description
IV injection 100 mcg
Primary Outcome Measure Information:
Title
Area under the plasma concentration vs time curve from time zero extrapolated to infinity
Description
a pharmacokinetic measure of the amount of study medication present in the blood
Time Frame
24 hours
Title
AUC from time zero to time of last quantifiable analyte concentration
Description
a pharmacokinetic measure of the amount of study medication present in the blood
Time Frame
96 hours
Title
Half-life associated with terminal slope of a semi-logarithmic concentration-time curve
Description
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
Time Frame
24 hours
Title
Total body clearance following iv administration
Description
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
Time Frame
24 hours
Title
Volume of distribution following iv administration
Description
a theoretical estimate of how much of the study drug that the body may contain
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of subjects with adverse events
Description
how many participants have reported a drug related advers event
Time Frame
5 days
Title
Number of subjects with clinically significant changes in vital signs
Description
how many participants have had any clinically significant changes in vital signs
Time Frame
5 days
Title
Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs)
Description
how many participants have had study drug related changes to cardiac function
Time Frame
5 days
Title
Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis
Description
how many participants have had study drug related changes in laboratory test analyses
Time Frame
5 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy males aged >18 and <65 years. Signed and dated informed consent prior to any study-mandated procedure Willing and able to comply with study requirements. BMI >18.0 and <30.0 kg/m^2 Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP. Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator. Exclusion Criteria: History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. Any planned major surgery within the duration of the study. Clinically relevant findings in laboratory parameters, ECG or vital signs at screening History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity Regular use of any prescribed or non-prescribed medication Planned treatment or treatment with another investigational drug within 3 months Current smokers or users of nicotine products. Positive screen for drugs of abuse or alcohol at screening History of alcohol abuse or excessive intake of alcohol Presence or history of drug abuse History of, or current use of, anabolic steroids. Excessive caffeine consumption Plasma donation within one month of screening or blood donation during the 3 months prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Sandin
Organizational Affiliation
AlzeCure Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856

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