Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856

Alzheimer Disease Clinical Trial

Official title:

A Phase 0, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics of a Single Intravenous Microdose of ACD856 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05783830
• Other study ID #: D2000C0-001
• Status: Completed
• Phase: Early Phase 1
• Start date: January 13, 2020
• Est. completion date: April 18, 2020

Study information

• Verified date: March 2023
• Source: AlzeCure Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 18, 2020
• Est. primary completion date: April 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorder
• Cognition Disorders

Intervention

Drug:
• ACD856
IV injection 100 mcg

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AlzeCure Pharma

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours
Primary	AUC from time zero to time of last quantifiable analyte concentration	a pharmacokinetic measure of the amount of study medication present in the blood	96 hours
Primary	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	24 hours
Primary	Total body clearance following iv administration	a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood	24 hours
Primary	Volume of distribution following iv administration	a theoretical estimate of how much of the study drug that the body may contain	24 hours
Secondary	Number of subjects with adverse events	how many participants have reported a drug related advers event	5 days
Secondary	Number of subjects with clinically significant changes in vital signs	how many participants have had any clinically significant changes in vital signs	5 days
Secondary	Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs)	how many participants have had study drug related changes to cardiac function	5 days
Secondary	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	5 days