Actively Recruiting
Nalmefene Implant in Healthy Subjects
Led by ReacX Pharmaceuticals, Inc. · Updated on 2026-04-06
24
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
Sponsors
R
ReacX Pharmaceuticals, Inc.
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nalmefene Implant in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, non-smoker, aged 18 to 55 years
- Body mass index between 18.5 and 35.0 kg/m2
- Body weight at least 50.0 kg for males and 45.0 kg for females
- Healthy with no significant illness or surgery within 4 weeks before implant insertion
- No significant history of dermatologic, neurological, musculoskeletal, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disease
- Female participants of non-childbearing potential must be post-menopausal with documented hormone test or surgically sterile
- Female participants of childbearing potential who are sexually active with a non-sterile male partner must agree to use acceptable contraception during the study and for 30 days after implant removal
- Male participants who are not vasectomized and sexually active with female partners of childbearing potential must agree to use acceptable contraception during the study and for 30 days after implant removal
- Able to understand study procedures and provide signed informed consent
You will not qualify if you...
- Any clinically significant abnormal findings on physical exam at screening
- History or current evidence of suicidal ideation or active suicidal behavior
- History or current evidence of depression
- Abnormal laboratory or positive tests for hepatitis B, hepatitis C, or HIV
- Positive pregnancy test or lactating female
- Positive urine drug screen, cotinine test, or alcohol breath test
- Known intolerance or allergic reactions to nalmefene or ethylene vinyl acetate
- Hypersensitivity to lidocaine, local anesthetics, epinephrine, or antiseptic solutions
- Significant ECG abnormalities or vital sign abnormalities
- History of drug use within 1 year or recreational marijuana use within 1 month
- History of alcohol abuse within 1 year
- Use of depot injection or implant within 3 months, drugs inducing liver metabolism within 30 days, prescription medications within 14 days, vaccines within 14 days, or over-the-counter/natural products within 7 days prior to implant
- Participation in other clinical research involving drugs or devices within 30 days
- Plasma donation within 7 days prior to dosing
- Difficulty with venipuncture or venous access
- History of wound healing problems
- Lymphedema, scarring, or tattoos on inner upper arms within 2 months or history of keloid scarring
- Any dermatologic disorder including cancer that affects implant safety
- Any other condition that would prevent participation as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Premier Research
Morrisville, North Carolina, United States, 27560
Actively Recruiting
Research Team
R
Rajesh Patel, PhD
CONTACT
S
Susan Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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