Pain Chronic pain
Conditions
Interventions
Capsules of 25mg, 75mg, 150mg, 300mg, 600mg, 900mg, 1200mg ALKS 6610 or
placebo.
Sponsors
Alkermes, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any study-mandated procedure 2. Ability to communicate well with the Investigator in the Dutch language and willing to follow the procedures and comply with study restrictions as outlined in the protocol 3. Male or female age >=18 years and =18 and
Exclusion criteria
Exclusion criteria: 1. Clinically significant illness or disease (e.g. psychiatric disorders, disorders of the gastrointestinal tract, liver [including Gilbert*s syndrome], kidney [including nephrectomy], respiratory system, endocrine system, haematological system, neurological system, or cardiovascular system, infection, or subjects who have a congenital abnormality in metabolism) within 8 weeks of dosing, or any clinically abnormal symptom or organ impairment, as judged by the Investigator, found by medical history, physical examinations, vital signs, electrocardiogram (ECG) finding, or either abnormal laboratory values or laboratory test results at Screening or Baseline (either Day -2 or Day -1) 2. Presence of any condition in which an opioid is contraindicated (e.g. respiratory depression, asthma, sleep apnea, ileus, etc.), unless regarded not clinically significant by the Investigator 3. Females who are breastfeeding or pregnant at Screening or Baseline (Day -2) (documented by a negative β human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG [or hCG]). A negative urine pregnancy test is required before the administration of the first dose per cohort 4. Females of childbearing potential. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, and without other known or suspected cause) or have been sterilized surgically (i.e. bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 6 weeks before dosing) 5. Any history of gastrointestinal surgery that may affect PK profiles of ALKS 6610 (e.g. hepatectomy, digestive organ resection) or other conditions that may impact absorption (malabsorption syndrome, inflammatory bowel disease, etc.) at Screening 6. A prolonged QT/QTc interval (QTcF >450 ms in males, and QTcF >470 ms in females) demonstrated on ECG at Screening or Baseline (either Day -2 or Day -1). A history of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT Syndrome) 7. Left bundle branch block at Screening or Baseline (either Day -2 or Day -1) 8. Systolic blood pressure (BP) >140 or 90 or <50 mmHg at Screening or Baseline (either Day -2 or Day -1) or history of clinically relevant orthostatic hypotension 9. Heart rate less than 45 beats per minute (bpm) or more than 100 bpm at Screening or Baseline (either Day -2 or Day -1) 10. History of myocardial infarction, ischemic heart disease, or cardiac failure at Screening 11. History of clinically significant arrhythmia or uncontrolled arrhythmia as determined by the Investigator at screening 12. Subjects who have demonstrated allergic reactions (e.g. food, drug, atopic reactions or asthmatic episodes) which, in the opinion of the Investigator, interfere with their ability to participate in the trial 13. Positive Hepatitis A antibodies (HAV IgM), Hepatitis B surface antigen (HBsAg), Hepatitis B antibodies (Anti-HBc), Hepatitis C antibodies (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at Screening 14. Use of nicotine containing products within 2 weeks before the first dose of study drug (Da
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability / Safety Endpoints Pharmacokinetic Endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic Endpoints | — |
Countries
Netherlands
Outcome results
None listed