Phase 1 drug study Nervous System Diseases
Conditions
Interventions
Current interventions as of 11/01/2024:
Part 1 SAD: Participants will be randomized to receive oral ALKS 2680 or placebo for 1 day. Part 2 MAD: Randomized to receive oral ALKS 2680 or placebo for 10
Sponsors
Alkermes (United States)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 11/01/2024: 1. Is a healthy male or female aged 18 to 65 years at the time of informed consent. 2. Is willing and able to provide informed consent before study participation, as required by local regulations and Independent Ethics Committee (IEC) requirements. 3. Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including adherence to contraception requirements. 4. Has a body mass index (BMI) =18 and =30 kg/m² at Screening. Parts 4-6 Only 6. Has a diagnosis of NT1, NT2, or IH according to ICSD-3 guidelines. 7. Has residual EDS (ie, ESS total score >10, referencing the week immediately prior) at Visit 2. 8. Is willing and able to discontinue any medications prescribed for the management of narcolepsy or IH symptoms including EDS and/or cataplexy at least 14 days (or 5 half-lives, whichever is longer) prior to Visit 2 to enable sufficient washout and resolution of any withdrawal symptoms. 9. Has a BMI =18 and =40 kg/m² at Screening. _____ Previous inclusion criteria: 1. Is a healthy male or female aged 18 to 65 years at the time of informed consent. 2. Is willing and able to provide informed consent before study participation, as required by local regulations and Independent Ethics Committee (IEC) requirements. 3. Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including adherence to contraception requirements. 4. Has a body mass index (BMI) =18 and =30 kg/m² at Screening.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 11/01/2024: 1. Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Screening. 2. Is currently pregnant, breastfeeding, or is planning to become pregnant during the study. 3. Does not have a history or presence of any clinically significant (treated or untreated) illness, disease, abnormality, behavioral or psychiatric disorder, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject’s ability to complete the trial. 4. Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at In-clinic Admission. 5. Has a history or presence at Screening of any clinically significant (treated or untreated) illness, disease, abnormality, behavioral or psychiatric disorder or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject’s ability to complete the trial. 6. Has a history or presnce at Screening of any significant cardiovascular disease (eg, myocardial infarction, ischemic heart disease, cardiac failure, arrhythmia). 7. Has a corrected QT interval (Fridericia correction; QTcF) >450 milliseconds (msec) if male and >470 msec if female, PR interval >210 msec, or any other ECG finding at Screening or upon admission, confirmed by repeat testing, that, in the opinion of the Investigator, might compromise subject safety. 8. Has a history of left bundle branch block or evidence of same on ECG at Screening or Baseline. 9. Has persistent systolic BP >[140] or [90] or 100 beats/min at Screening or Baseline. 11. Is employed by Alkermes, the contract research organization (CRO), or study site (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family (ie, a spouse, parent, sibling, or child, whether biological or legally adopted) of an Alkermes, CRO, or study site employee. 12. Consumes more than 400 mg of caffeine (ie, >5 cups of coffee) per day or has substantial changes in caffeine consumption in the 30 days prior to Screening. 13. Consumes more than 20 grams of alcohol (ie, >2 “standard” drinks in Australia ) per day or has substantial changes in alcohol consumption in the 30 days prior to Screening. 14. Consumes nicotine daily (ie, =1 cigarette, vaping or chewing tobacco, nicotine patch or gum) or has substantial changes in nicotine consumption in the 30 days prior to Screening. 15. Consumes cannabis or cannabis-derived compounds (eg, marijuana cigarettes, vaping, edibles, beauty and skincare products, or oils containing cannabidiol [CBD] and/or tetrahydrocannabinol [THC]) more than 3 times per month or has substantial changes in cannabis consumption in the 30 days prior to Screening. 16. Has a substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition; DSM-5) guidelines, including use of alcohol, nicotine, cannabis, narcotics, or any illicit substance. 17. Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at In- clinic Admission. 18. Has active suicidal ideation or any history of suicidal behavior; or has a “Yes” to any of the five yes/no questions on the Colu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 11/01/2024: Parts 1,2,3,4,5,6 1. Incidence of treatment-emergent adverse events assess throughout the trial (enrollment to study follow-up) _____ Previous primary outcome measure: Parts 1,2,3 1. Incidence of treatment-emergent adverse events assess throughout the trial (enrollment to study follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/01/2024: Part 1 & 3 1. Levels of ALKS 2680 in blood measured as Cmax , Tmax (Day 1), AUC (over 12 hours), T-half, CL/F, and Vz/F using non-compartmental methods Part 2 1. Levels of ALKS 2680 in blood and urine measured as Cmax , Tmax (Day 1), AUC (over 7 days) T- half, CL/F, and Vz/F using non-compartmental methods Parts 4 & 6 1. Levels of ALKS 2680 in blood and urine measured as Cmax , Tmax (Day 1), AUC (over 8 hours) T- half, CL/F, and Vz/F using non-compartmental methods 2. Change from Baseline to post-dose on dosing days in the average sleep latency across the first 4 sessions of the Maintenance of Wakefulness Test (MWT) _____ Previous secondary outcome measures: Part 1 & 3 1. Levels of ALKS 2680 in blood measured as Cmax , Tmax (Day 1), AUC (over 12 hours), T-half, CL/F, and Vz/F using non-compartmental methods Part 2 1. Levels of ALKS 2680 in blood and urine measured as Cmax , Tmax (Day 1), AUC (over 7 days) T-half, CL/F, and Vz/F using non-compartmental methods | — |
Countries
Australia, United States of America
Contacts
Public ContactClinical Operations
Outcome results
None listed