Safety and Pharmacokinetics of ALZ-507 in Healthy Elderly Adults
ConditionHealthy Participants Study
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-75
SponsorAlzheon Inc.
About this trial
Researchers are testing an investigational medicine called ALZ-507 in healthy adults between 50 and 75 years of age.
The purpose of this study is to learn:
Assess if oral ALZ-507 is safe What side effects may occur How the body absorbs ALZ-507 Whether food affects how ALZ-507 is absorbed How much ALZ-507 reaches the blood, cerebrospinal fluid, and urine
Participants will receive either ALZ-507 or a placebo. Some participants will receive a single dose, while others will receive daily doses for two weeks. Researchers will monitor participants closely through medical examinations, laboratory testing, and collection of blood, cerebrospinal fluid and urine.
The findings from this study will help guide the future development of ALZ-507.
The information from this study will help determine whether ALZ-507 is safe for further clinical development.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy males and females aged 50 to 75 years, inclusive
Body mass index 18.0 to 35.0 kg/m2, inclusive, and >50 kg body weight
No clinically significant values for vital signs (systolic blood pressure [BP] 90 to 140 mmHg, diastolic BP 40 to 90 mmHg, and HR 50 to 100 bpm) and no clinically significant ECG readings, as determined by the principal investigator or sub investigator
Disqualifiers
Participation in a clinical research study within the previous 30 days or within a period of less than 5 times the drug's half-life
Have previously participated in a trial with ALZ-801 or tramiprosate and received study drug
History of any drug or alcohol abuse in the past 2 years
Creatinine clearance of <60 mL/min using the Cockcroft-Gault equation at screening
Trial design
Design model
Sequential
Treatments tested in this trial
ALZ-507
DrugParticipants will receive ALZ-507 oral capsules administered as single ascending doses in Part 1 or once daily for 14 days as multiple ascending doses in Part 2
Placebo
DrugMatching placebo capsules administered orally according to the same dosing schedule as ALZ-507
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Placebo-ControlledPlacebo comparator 1 intervention
Group B: Experimental ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Single Ascending Doses of ALZ-507
Time frame
From first dose through the follow-up visit (up to approximately 31 days in Part 1 and up to approximately 35 days in Part 2).Secondary outcomes
1
Maximum observed plasma concentration (Cmax) of ALZ-507 following single ascending doses
Time frame
Predose through 144 hours (7 days) after administration of a single dose of ALZ-5072
Maximum observed plasma concentration (Cmax) of ALZ-507 under fed and fasted conditions
Time frame
Predose through 144 hours (7 days) after administration of a single dose of ALZ-507 under fed and fasted conditions3
Steady-state maximum observed plasma concentration (Cmax,ss) of ALZ-507 after multiple ascending doses
Time frame
Predose on Day 1 through 144 hours after the final dose on Day 14 (up to Day 20)4
Amount of ALZ-507 excreted in urine at steady state
Time frame
Day 14 through Day 20Sponsors and contacts
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Source ClinicalTrials.gov