Alzheimer's disease Dementia
Conditions
Interventions
The subjects will receive a single dose of ALK 7119 or placebo.
Sponsors
Alkermes, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Netherlands
Outcome results
None listed