A study in healthy subjects to see the effects of the test medicine ALKS 2680 in single and multi-dose regime
- Conditions
- Phase 1 drug studyNervous System Diseases
- Registration Number
- ISRCTN98204977
- Lead Sponsor
- Alkermes (United States)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 147
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.
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] mmHg or diastolic BP >[90] or <[50] mmHg at Screening or Baseline, or history of orthostatic hypotension.
10. Has persistent HR <45 beats/min 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measure as of 11/01/2024: <br><br>Parts 1,2,3,4,5,6<br>1. Incidence of treatment-emergent adverse events assess throughout the trial (enrollment to study follow-up)<br><br>_____<br><br>Previous primary outcome measure:<br><br>Parts 1,2,3<br>1. Incidence of treatment-emergent adverse events assess throughout the trial (enrollment to study follow-up)
- Secondary Outcome Measures
Name Time Method