To evaluate the safety and tolerability of ENX-102 following repeated doses in healthy volunteers
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The safety and tolerability of ENX-102 will be assessed by the following:
• AEs
• Vital signs (2 positional blood pressure and HR, respiratory rate, and
tympanic body temperature)
• 12 lead ECG
• Clinical laboratory tests (hematology, serum chemistry, urinalysis)
• Physical examination
• Pregnancy test (where applicable)
• C SSRS
• MOAA/S
Secondary outcome
Pharmacokinetic Measures:
- Maximum plasma concentration (Cmax)
- Time to reach maximum plasma concentration (Tmax)
- Area under the plasma concentration time curve (AUC) from administration to
the end of dosing (AUC0 t),
- AUC from administration to 24 h after dosing (AUC0 24), AUC extrapolated to
infinite time (AUC0 *),
- Plasma concentration half life (t1/2),
- Terminal rate constant (*z),
- Apparent total clearance of the drug from plasma after oral administration
(CL/F),
- Apparent volume of distribution during terminal phase after non intravenous
administration (Vz/F).
Pharmacodynamic Measures:
• NeuroCart assessments
- Saccadic eye movements, saccadic reaction time (seconds), saccadic peak
velocity (degrees/second), and saccadic inaccuracy (%)
- Smooth pursuit eye movements (percentage of time the eyes of the subject are
in smooth pursuit of the target) (%)
- Adaptive tracking (average performance) (%)
- Body sway (antero posterior sway) (mm)
- Pupil size
- VAS according to Bond and Lader to assess mood, alertness, and calmness (mm)
• Cognitive assessment
o VVLT (Learning and Immediate Recall, Delayed Recall, and Delayed Recognition)
• qEEG
Background summary
This Phase 1 study will investigate the safety and tolerability, and determine
the pharmacokinetic(PK) and pharmacodynamic(PD) profile of ENX-102 in healthy
subjects after administration of multiple doses, as part of clinical
development before administering this drug to patients.
Study objective
To evaluate the safety and tolerability of ENX-102 following repeated doses in
healthy volunteers
Study design
This is a randomized, double blind, placebo controlled, multiple ascending dose
study in healthy volunteers.
Intervention
ENX 102 (oral capsules) or placebo (oral capsules) once daily for 12
consecutive days.
Study burden and risks
For this study, healthy male and female participants aged 18 to 55 (inclusive)
were chosen because of the absence of potentially confounding disease
processes, which will lead to a clearer and more consistent assessment of drug
disposition and biological activity. No therapeutic benefit is expected for
participants in this study, as is common for most Phase 1 studies with healthy
participants.
High Bluff Drive, Suite 190 12750
San Diego CA 92130
US
High Bluff Drive, Suite 190 12750
San Diego CA 92130
US
Listed location countries
Age
Inclusion criteria
- Healthy male and female volunteers aged 18 to 55 years, inclusive, at
Screening
- Capable of giving written informed consent
- Willing to give written consent to have data entered into "Verified Clinical
Trials"
- Female subjects
a. Of non childbearing potential, defined as either permanently sterilized (at
least 4 months after surgical sterilization including bilateral salpingectomy,
tubal ligation, or oophorectomy with or without hysterectomy) or post
menopausal (defined as amenorrhea for 12 consecutive months and documented
plasma follicle stimulating hormone level >40 IU/mL; in the event a subject's
menopausal status has been clearly established and yet serum follicle
stimulating hormone levels are not consistent with a post menopausal status,
determination of the subject's eligibility to be included in the study will be
at the Investigator's discretion following consultation with the Sponsor), and
with a negative pregnancy test at Screening and Day -1; OR
b. Of childbearing potential and willing to use 2 effective methods of
contraception (i.e., established method of contraception + condom) or remain
abstinent (where abstaining from sexual intercourse is in line with the
preferred and usual lifestyle of the subject) from Day -1 through 3 months
after the last dose of study drug, and with a negative pregnancy test at
Screening and Day -1
- Male subjects who, if fertile (defined as post pubertal and not permanently
sterile by orchidectomy or vasectomy) must be willing to use a condom or remain
abstinent (where abstaining from sexual intercourse is in line with the
preferred and usual lifestyle of the subject) from Day -1 through 3 months
after the last dose of study drug
- Body mass index of 18 to 35 kg/m2 at Screening
- Willing and able to comply with all study requirements including the
following:
a. Reside in the inpatient unit from Day -1 until discharge on Day 13
b. Refrain from strenuous exercise from Day -4 until Day 26
c. Abstain from grapefruit , alcohol , caffeine , or xanthine containing
products from Day -4 through Day 26
Exclusion criteria
- Clinically significant abnormality within 2 years of Screening that in the
Investigator's opinion may place the subject at risk or interfere with
study outcome variables; this includes, but is not limited to, history of or
current cardiac, renal, neurologic, gastrointestinal, pulmonary,
endocrinologic, hematologic, or immunologic disease or history of malignancy
- Reports having experienced suicidal ideation (Type 4 or 5 on the CSSRS)
within 30 days prior to Screening, any suicidal behavior within 2
years prior to Screening (any "Yes" answers on Suicidal Behavior section of
C*SSRS), and/or the Investigator assesses the subject to be a safety risk to
him/herself or others
- History or evidence of moderate or severe Substance Use Disorder as defined
by the Diagnostic and Statistical Manual of Mental Disorders (5th Edition)
- Clinically significant abnormal findings in serum chemistry, coagulation,
hematology, or urinalysis results at Screening or Day -1
- Clinically significant abnormal findings in vital sign assessments at
Screening or Day -1
- History of hepatitis B or hepatitis C or demonstration of hepatitis B surface
antigen or hepatitis C antibody at Screening
- History of HIV infection or demonstration of HIV antibodies at Screening
- Receipt of an investigational drug within 90 days or 5 half*lives, whichever
is longer, prior to Day 1 or currently in the follow*up period of another
clinical trial at the time of Screening
- Any other condition that, in the Investigator's opinion, might indicate that
the subject is unsuitable for the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-004112-25-NL |
| CCMO | NL78813.056.21 |