Evaluating the safety, tolerability, and pharmacodynamic properties of IW-6463 in healthy elderly subjects.
- Conditions
- Alzheimer's diseaseDementia10057167
- Registration Number
- NL-OMON48314
- Lead Sponsor
- Cyclerion Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Each participant must meet each of the following criteria to be eligible for
enrollment in this study.
1. Signed an informed consent form (ICF) before any study-specific procedures
are performed.
2. Is fluent in the written and spoken language of the local ICF (ie, Dutch).
3. Age is *65 years at the day of first dose administration.
4. Ambulatory and in good health as defined by the absence of evidence of any
clinically relevant active or chronic disease following detailed medical and
surgical history review and a complete physical examination including vital
signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
a. Note: The Investigator will determine whether a particular finding is
clinically significant. In making this determination, the Investigator will
consider whether the particular finding could prevent the participant from
performing any of the protocol-specified assessments, could represent a
condition that would exclude the participant from the study, could represent a
safety concern if the participant participates in the study, or could confound
the study-specified assessments
5. Able to understand the commitments of the study, to communicate effectively
with the investigator and site staff and agrees to adhere to all study
requirements, including the lifestyle restrictions.
6. Able to undergo MRI scanning procedures.
7. Body mass index is *18 and <32 kg/m2 at the Screening Visit.
8. Supine systolic blood pressure (BP) is in the range of 100 to 160 mmHg,
inclusive; and supine diastolic BP is in the range of 60 to 95 mmHg, inclusive,
at the Screening Visit.
Note: Screening BP will be the average of 2 measurements obtained with an
appropriately sized cuff at 2 minute intervals after the participant has been
resting quietly in a supine position for *5 minutes.If the average systolic BP
is between 150 and
160 mmHg at Screening, confirmation excluding a history of hypertension will be
obtained. No more than 4 subjects with systolic BP in this range will be
enrolled in each
cohort.
9. Agrees to refrain from making any major lifestyle changes (e.g., start a new
diet or change an exercise pattern) from the time of signature of the ICF until
after the Follow-up Period.
10. Female participants must be postmenopausal. A postmenopausal state is
defined as no menses for *12 consecutive months without an alternative medical
cause. A high follicle-stimulating hormone (FSH) level at screening (>40 IU/L
or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal
state.
11. Male participants who have not been surgically sterilized by vasectomy
(conducted *60 days before the Screening Visit or confirmed via sperm analysis)
must agree to use *1 of the following effective contraception methods from the
date of signing the ICF until 90 days after receiving his final study drug dose:
a. Completely abstain from heterosexual intercourse with non-menopausal women *
or*
b. If heterosexually active with women of reproductive potential, use, or have
their sexual partners use:
* Intrauterine device *or*
* Combination of 2 highly effective birth control methods (e.g., condom with
spermicide + diaphragm or cervical cap; hormonal contraceptive [e.g., oral or
transdermal patch or progesterone implant] + barrier method) *or*
* Maintenance
A participant who meets any of the following criteria will be excluded from the
study.
1. Clinically relevant history of abnormal physical or mental health
interfering with the study as determined from the medical history review and
the physical examinations obtained during the screening visit and/or at the
start of the first study day for each period as judged by the investigator
including (but not limited to), neurological, psychiatric, endocrine,
cardiovascular (including recent myocardial infarction), respiratory,
gastrointestinal, hepatic, renal disorder or presence of narrow-angle glaucoma)
psychiatric (including history of clinical depression or suicidal ideation); or
neurological disorder.
2. 12-lead ECG at the Screening Visit demonstrating severe bradycardia (heart
rate [HR] <40 beats per minute) or average QT interval corrected for HR using
Fridericia*s formula (QTcF) *450 msec for men or *470 msec for women.
3. Family history of short QT syndrome or long QT syndrome.
4. History or clinical evidence of any disease and/or existence of any surgical
or medical condition that might interfere with the absorption, distribution,
metabolism, or excretion of the study drugs.
5. History of severe allergies, or history of an anaphylactic reaction to
prescription or non-prescription drugs or food.
6. Positive test for hepatitis B surface antigen (HBsAg), hepatitis B core
antigen antibody
[anti-HBc], hepatitis C antibody (HCV Ab), or human immunodeficiency virus
antibody (HIV Ab) at screening.
7. Clinically significant hypersensitivity or allergy to any of the inactive
ingredients contained in the active or placebo drug products.
8. Clinically relevant positive urine drug screen (UDS) or alcohol test at
screening and/or upon admission to the Clinical Research Unit (CRU) before each
dosing period.
9. Presence or history (within 3 months of screening) of alcohol abuse
confirmed by medical history, or daily alcohol consumption exceeding 2 standard
drinks per day on average for females or exceeding 3 standard drinks per day on
average for males (1 standard drink=10 grams of alcohol), and the inability to
refrain from alcohol during the visits until discharge from the CRU (alcohol
consumption will be prohibited during study confinement).
10. Any concurrent disease or condition that could interfere with, or for which
the concomitant treatment might interfere with, the conduct of the study or
that would, in the opinion of the Investigator, pose an unacceptable risk to
the participant in this study.
11. Received IW-6463 in a prior study, participated in an investigational drug
trial in the 3 months prior to administration of the initial dose of study drug
or in more than 4 trials in the prior 12 months, is planning to receive another
investigational drug at any time during the study, has an active
investigational medical device currently implanted, and/or is planning to have
an investigational medical device implanted at any time during the study.
12. Donation or loss of blood of more than 500 mL within 3 months (males) or 4
months (females) prior to screening and/or donated any plasma within 2 weeks of
the Screening Visit.
13. Elevated levels (ie, >1.5× the upper limit of normal as defined by the
laboratory) at the Screening Visit or at Day 1 of alanine aminotrans
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method