Nalmefene Implant in Healthy Subjects
ConditionOpioid Abuse and Addiction
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorReacX Pharmaceuticals, Inc.
About this trial
The goal of this clinical trial is to learn how safe either one or two nalmefene implants are after remaining implanted for 4 or 12 weeks.
Additionally the pharmacokinetics (PK), how fast the drug is absorbed into the body and how long it remains in the body, will also be studies.
The data collected in this healthy volunteer study will inform the Sponsor on how best to proceed with future trials in the intended patient population.
Eligibility criteria
Qualifiers
Male or female, non-smoker, ≥18 and ≤55 years of age, with body mass index (BMI) >18.5 and <35.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
the absence of clinically significant illness and surgery within 4 weeks prior to implant insertion.
the absence of clinically significant history of dermatologic, neurological, musculoskeletal, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
post-menopausal with confirmation by documented follicle-stimulating hormone (FSH) test; or
Disqualifiers
Any clinically significant abnormal finding at physical examination at screening.
Clinically significant history of or current evidence of suicidal ideation or active suicidal behavior as based on the C-SSRS.
Clinically significant history or current evidence of depression as based on the MADRS.
Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
Trial design
Treatments tested in this trial
- 1 Nalmefene implant
- 2 Nalmefene implants
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
ReacX Pharmaceuticals, Inc.
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov