To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ALKS 7119 following oral administration of single ascending doses of ALKS 7119 in healthy male adults
ID
Source
Brief title
Condition
- Neurological disorders NEC
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At a minimum, the following PK parameters will be determined for ALKS 7119.
* Cmax
* Time to Cmax (Tmax)
* Terminal elimination half-life (t*)
* Area under the concentration-time curve from time zero to the last
quantifiable time interval (AUClast)
* Area under the concentration-time curve from time zero to infinity (AUC*)
Additional PK parameters may be determined as appropriate.
The pharmacodynamics of ALKS 7119 will be evaluated via a battery of tasks,
including saccadic eye movements, smooth pursuit eye movements, adaptive
tracking performance test, pupillometry, Visual Analog Scales (Bond and Lader,
and Bowdle scales), the Visual Verbal Learning Test, and
pharmaco-electroencephalography (EEG). In addition, blood cortisol measurements
will be collected.
Evaluation of safety will be based on vital signs, blood clinical biochemistry
and hematology, urinalysis, physical examinations, safety 12-lead
electrocardiograms (ECGs), real-time ECG monitoring, and adverse events (AEs).
Secondary outcome
NA
Background summary
Emerging studies point to a potential role for NMDA antagonists in treating
behavioral symptoms associated with Alzheimer*s disease, including agitation
[Cummings, 2014;Wilcock, 2008]. There are currently no approved drugs in the US
for treating these symptoms, which diminish quality of life for patients and
caretakers and correlate with a poorer disease prognosis. Developing drugs for
this indication therefore represents a significant clinical need. As a
low-affinity antagonist at the NMDA receptor, Alkermes postulates that ALKS
7119 may be applicable for this purpose.
Study objective
To evaluate the safety, tolerability, pharmacokinetics (PK), and
pharmacodynamics (PD) of ALKS 7119 following oral administration of single
ascending doses of ALKS 7119 in healthy male adults
Study design
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled
study to evaluate the safety, tolerability, PK, and PD of single ascending
doses of ALKS 7119 in healthy male adults. Up to 10 cohorts are planned with 10
subjects per cohort and a total of 100 randomized subjects.
Potential subjects will be screened up to 21 days prior to administration of
study drug. Dosing of cohorts will be separated by at least 7 days to allow
adequate time for a review of all safety, PD, and PK data from the most
recently dosed cohort.
The study duration for a given subject is expected to be up to 4.5 weeks, which
includes up to 3 weeks for screening, an inpatient stay from Day -1 to Day 2,
and a follow-up visit between Day 8 and 11.
Intervention
The subjects will receive a single dose of ALK 7119 or placebo.
Study burden and risks
There is no health benefit for participants. Risk is considered minimal. Burden
consists of time investment and life style restrictions.
Winter Street 852
Waltham MA 02451
US
Winter Street 852
Waltham MA 02451
US
Listed location countries
Age
Inclusion criteria
1. Is willing and able to give informed consent
2. Is capable of understanding and complying with the protocol
3. Is male, and *18 and *45 years of age at screening
4. Has a body-mass index *18.0 and *32.0 kg/m2 at screening
5. Agrees to use an acceptable method of contraception for the duration of the study as outlined in Section 9.4.1 of the protocol and for 90 days after any study drug administration
Exclusion criteria
1. Has a clinically significant medical condition or observed abnormalities in the opinion of the Investigator (including physical examination results, vital sign results, ECG results, laboratory blood sample test results [particularly kidney function, liver function, and hematology test results], and urinalysis)
2. Has a corrected QT interval (Fridericia correction; QTcF) t;450 milliseconds, PR interval t;220 milliseconds, or any other ECG finding that, in the opinion of the investigator, might compromise subject safety
3. Has a thyroid stimulating hormone (TSH) level greater than 10% above or below the normal range at screening
4. Has a history of intolerance or hypersensitivity to dextromethorphan or any dextromethorphan-containing product
5. Has had a clinically significant illness in the 30 days prior to first study drug administration (Day 1)
6. Has a positive drug screen for alcohol, amphetamines, methamphetamine, barbiturates, benzodiazepines, cocaine, tetrahydrocannabinol (THC), methadone, or opiates at screening or upon inpatient admission
7. Has a positive serology test for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus antibody (HIVAb) at screening
8. Has a lifetime history of diabetes or Hemoglobin A1c (glycosylated hemoglobin) >6% at screening
9. Has used any prescription or over-the-counter medication, including herbal remedies and nutritional supplements (except vitamins), within 7 days prior to screening or inpatient admission
10. Has ingested any alcohol, caffeine, or xanthine within 24 hours prior to inpatient admission, or excessive caffeine consumption (defined as *800mg per day) at screening
11. Has used any product containing nicotine within 30 days prior to the inpatient admission
12. Has participated in a clinical trial of an investigational product within 3 months or participated in more than four investigational drug studies within 1 year prior to screening
13. Has lost >500 mL of blood or donated blood within 90 days prior to inpatient admission or donated blood product of any type (eg, plasma) within 14 days prior to inpatient admission
14. Has a history of treatment non-adherence or poor clinic visit attendance or the principal investigator (PI) or designee has reason to believe that the subject may be unable to fulfill the protocol visit schedule or requirements
15. Requires a special diet, has a significant food allergy or intolerance, or is not willing to abide by the diet provided by the site
16. Is employed by Alkermes, the investigator or study site, (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family* of an Alkermes, investigator, or study site employee
* Immediate family is defined as a spouse, parent, sibling, or child, whether biological or legally adopted
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 | EUCTR2015-004488-35-NL |
| CCMO | NL55561.056.15 |