Alzheimer's disease Dementia
Conditions
Interventions
The subjects will receive multiple doses of ALKS 7119 or placebo.
Sponsors
Alkermes, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Is willing and able to provide informed consent 2. Is capable of understanding and complying with the protocol 3. Is male or female adult and *18 and *45 years of age, inclusive, at screening (Visit 1) 4. Has a body mass index *18.0 and *32.0 kg/m2 at screening 5. Agrees to use an acceptable method of contraception from 30 days prior to screening and for 90 days after any study drug administration, or must be surgically sterile or post-menopausal (if female)
Exclusion criteria
Exclusion criteria: 1. Clinically significant medical condition or observed abnormalities, in the opinion of the investigator (including, clinically significant physical examination finding, vital sign result, ECG result, laboratory or urinalysis test result) and/or any other finding that, in the investigator*s judgment, could potentially compromise subject safety, or PK or PD evaluation, or affect the subject*s ability to adhere to the protocol visit schedule, or fulfill visit requirements 2. Female subject that is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the study and for 90 days after any study drug administration 3. Has a history of intolerance or hypersensitivity to dextromethorphan or any dextromethorphan-containing product 4. Has had a clinically significant illness in the 30 days prior to first study drug administration (Day 1) 5. Has a positive drug screen for at screening (Visit 1) or upon admission (Day -1) 6. Has a positive breath test for alcohol at screening (Visit 1) or upon admission (Day -1) 7. Has a positive serology test for hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus antibody (HIVAb) at screening (Visit 1) 8. Has a clinically significant lifetime history of suicidal ideation or suicidal behavior and/or poses a current (within past year) suicide risk 9. Has used any prescription or over-the-counter medication, including herbal remedies and nutritional supplements (except vitamins), within 7 days prior to screening (Visit 1) or admission (Day -1) 10. Has ingested any alcohol, caffeine or xanthine within 24 hours prior to inpatient admission (Day -1), or excessive caffeine consumption (defined as *800 mg per day) at screening (Visit 1) 11. Has used any product containing nicotine within 30 days prior to admission (Day -1) 12. Has participated in a clinical trial of an investigational product within 3 months prior to screening (Visit 1) or participated in more than four investigational drug studies within 1 year prior to screening (Visit 1) 13. Has previously participated in a clinical trial with ALKS 7119
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability: Evaluation of safety will be based on the occurrence of adverse events (AEs), vital signs, results of clinical laboratory tests electrocardiogram (ECG) parameters, real-time ECG parameters. Reported AE terms will be coded using the Medical Dictionary for Regulatory Activities (MedDRA® version 19.0 or higher) preferred terms and system organ classes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Concentrations of ALKS 7119 will be quantified in plasma samples collected for PK evaluation. Noncompartmental PK analyses will be performed to estimate the PK parameters. At a minimum, the following PK parameters will be determined for ALKS 7119, as applicable: * Maximum plasma concentration (Cmax) of ALKS 7119 on Day 1 and Day 14 * Area under the concentration-time curve from time zero to the last quantifiable time interval (AUClast) on Day 1 and Day 14 * Area under the concentration-time curve over the 24-hour dosing interval (AUC24h) of ALKS 7119 on Day 1 and Day 14 * Area under the concentration-time curve from time zero to infinity (AUC*) after the first dose on Day 1 * Time to Cmax (tmax) of ALKS 7119 on Day 1 and Day 14 * Terminal elimination half-life (t*) of ALKS 7119 on Day 1 and Day 14 * Trough plasma concentration (Ctrough) on Day 1 through Day 14 * Accumulation ratio (Day 14/Day 1 AUC24h ratio) Dose proportionality assessment and additional PK analyses may be performed as appropriate. | — |
Countries
Netherlands
Outcome results
None listed