Healthy volunteers Other
Conditions
Interventions
A total of 32 healthy volunteers will be randomized into one of four treatment groups in the study. In Period 1 of the study, two groups of 16 subjects each will be administered 7 repeated daily doses
Sponsors
Camurus AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary and valid written informed consent to participate in the study provided before performing any study-related procedures. 2. Male or female subjects aged 18 to 65 years old (inclusive) at the time of screening. 3. Body mass index range of 18.5 to 30.0 kg/m2, inclusive, and body weight of at least 50 kg at the time of screening. 4. Willing to abstain from activities that require focused attention, e.g. driving a car or other vehicles, operating machines, or engaging in potentially dangerous activities that require focused attention and intact physical balance during the study.
Exclusion criteria
Exclusion criteria: 1. Known contraindication or hypersensitivity to BPN, excipients of CAM2038, other opioids or naltrexone. 2. Clinically significant history of allergic conditions, including drug allergies, asthma (except childhood asthma), chronic eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies. 3. History or evidence of clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic (including any obstruction to urinary flow such as prostatic hypertrophy, urinary hesitancy etc.), pulmonary, neurologic (including history of fits), dermatologic, psychiatric, or renal disease, or other major disease or malignancy, as judged by the Investigator. 4. Clinically significant laboratory test result at screening that contraindicates study participation. 5. Use of any cytochrome P450 (CYP) 3A4-modifying drugs and/or other products, including strong or moderate inhibitors of CYP enzymes (e.g. cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals) and strong or moderate inducers of CYP enzymes (e.g. barbiturates, carbamazepine, glucocorticoids, phenytoin, St. John´s Wort and rifampicin) within 2 weeks before the first administration of SL BPN or less than 5 half-lives of the medication, whichever is longer. 6. Positive serology test for hepatitis B surface antigen, hepatitis C virus antibodies, or antibodies to HIV type 1 (HIV-1) and/or type 2 (HIV-2) at screening. 7. Pregnant, lactating, or planning to become pregnant during the study. 8. Female subject of childbearing potential unwilling to use a highly effective method of contraception during the study. 9. Male subject unwilling to use condoms with spermicide during the study. 10. Any condition requiring regular medication, including herbal products, or predicted need of any concomitant medication during the study. 11. Heart rate of 90 bpm, systolic blood pressure 140 mmHg or diastolic blood pressure 90 mmHg at the screening visit. 12. QTcF >450 ms for males and >470 ms for females at the screening visit, or a history of Torsades de Pointes, or familial long QT syndrome at screening. 13. History or presence of alcohol and/or drug dependence or addiction, or positive urine drug or alcohol screen at the screening visit or at any point prior to randomization. 14. Presence of excessive alcohol consumption (regular alcohol intake >21 units per week for males and >14 units of alcohol per week for females). One unit is equal to approximately 8 g of pure alcohol (200 mL) of beer (5%), one small glass (100 mL) of wine (10%), or 25 mL of spirits (40%). 15. Smoking more than 10 cigarettes (or an equivalent amount of tobacco) per day within 3 months before screening. 16. Intake of any food or any drinks containing grapefruit, Chinese grapefruit (pomelo) or Seville orange (including marmalade) within 48 hours before the first administration of SL BPN until Day 85/End of Study. 17. Excessive use of caffeine-containing beverages exceeding 500 mg caffeine/day (5 cups of coffee) and the inability to refrain from the use of caffeine-containing beverages for 24 hours before each visit and during confinement at the Unit. 18. Intake of any medication (except paracetamol up to 2 g per day), including over-the-counter medication, herbal and dietary supplements such as St John’s Wort, vitamins, and mineral
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BPN and norBPN PK parameters (Cmax, tmax, AUC0-inf, and t1/2) after a single dose of low-dose CAM2038. Blood samples will be taken pre-dose and at specified time points until Day 85/End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. BPN PK parameters for single dose CAM2038 (DAUC0-inf) and for steady-state SL BPN (DAUCt). Blood samples for SL BPN will be taken from Day 5 until 24 h after the last dose. Blood samples for CAM2038 will be taken pre-dose and at specified time points until Day 85/End of Study. 2. BPN and norBPN PK parameters (DCmax, DAUC0-last, DAUC0-inf) for single dose CAM2038. Blood samples will be taken pre-dose and at specified time points until Day 85/End of Study. 3. Adverse events, local tolerability and changes in laboratory values, vital signs and electrocardiogram parameters. Safety assessments will be performed throughout the study. | — |
Countries
England, United Kingdom
Contacts
Public ContactHead of Investor Relations Camurus
Outcome results
None listed