Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856
A Phase 0, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics of a Single Intravenous Microdose of ACD856 in Healthy Volunteers
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Jan 2020
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2020
CompletedFirst Submitted
Initial submission to the registry
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedMarch 24, 2023
March 1, 2023
3 months
April 1, 2021
March 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
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
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
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
Volume of distribution following iv administration
a theoretical estimate of how much of the study drug that the body may contain
24 hours
Secondary Outcomes (4)
Number of subjects with adverse events
5 days
Number of subjects with clinically significant changes in vital signs
5 days
Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs)
5 days
Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis
5 days
Study Arms (1)
ACD856
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AlzeCure Pharmalead
Study Sites (1)
Uppsala University Hospital
Uppsala, Sweden
Related Publications (1)
Nilsson B, Bylund J, Halldin MM, Rother M, Rein-Hedin E, Onnestam K, Segerdahl M. ACD856, a novel positive allosteric modulator of Trk receptors, single ascending doses in healthy subjects: Safety and pharmacokinetics. Eur J Clin Pharmacol. 2024 May;80(5):717-727. doi: 10.1007/s00228-024-03645-1. Epub 2024 Feb 14.
PMID: 38353689DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johan Sandin
AlzeCure Pharma
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2021
First Posted
March 24, 2023
Study Start
January 13, 2020
Primary Completion
April 18, 2020
Study Completion
April 18, 2020
Last Updated
March 24, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share