This is a single center, Phase 1, open-label, safety, tolerability, and PK study designed to compare one (1) or two (2) nalmefene implants in healthy subjects.
The study will include a screening period from Day -28 to Day -2, where subjects will be evaluated according to the Inclusion/Exclusion Criteria. Enrollment will be initially restricted to Cohort 1 (1 implant) until the Safety Review Committee (SRC) completes an evaluation of the safety data, of at least 5 subjects, through the Week 4 Visit. The SRC will then advise the Sponsor as to whether to open enrollment to Cohort 2 (2 implants).
Including screening, the first 8 subjects will be enrolled into Cohort 1 Subgroup 1 and will be seen for 16 visits over a period of up to 18 weeks. This includes a total of up to 8 nights of inpatient stay during that period. Eligible subjects will be admitted to the clinical site on Day -1 and implant insertion will occur on Day 1. Subjects will be confined until completion of the assessments on Day 2. Subjects will return to the clinical site for outpatient visits on Days 3 and 4, and Weeks 1, 2, 3, 4, 6, 8, and 10. Subjects will be admitted again two days prior to the Week 12/End of Treatment for an implant removal visit and will be discharged after the final blood sample is collected 72 hours after implant removal. Subjects will return to the clinical site for follow-up visits on Week 13 and Week 14 (1 and 2 week(s) following implant removal procedure) for removal of sutures (if any) and safety evaluations.
Including screening, subjects enrolled into Cohort 1 Subgroup 2 and Cohort 2 will be seen for approximately 22 visits over a period of up to 30 weeks. This includes a total of 8 nights of inpatient stay during that period. Eligible subjects will be admitted to the clinical site on Day -1 and implant insertion will occur on Day 1. Subjects will be confined until completion of the assessments on Day 2. Subjects will return to the clinical site for outpatient visits on Days 3 and 4, and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22. Subjects will be admitted again on the day prior to the Week 24/EOT implant removal visit and will be discharged after the final blood sample is collected 72 hours after implant removal. Subjects will return to the clinical site for follow-up visits on Week 25 and Week 26 (1 and 2 week(s) following implant removal procedure) for removal of sutures (if any) and safety evaluations.
