BridgeMD
New treatment option for Opioid Abuse and Addiction
Official title Nalmefene Implant in Healthy Subjects
ClinicalTrials.gov ID: NCT07325279
What this study is testing
What is 1 Nalmefene implant?
1 Nalmefene implant is an investigational medicine, being studied as a potential treatment for opioid abuse and addiction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- \- people must meet all of the following criteria to be included in the study:
- 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...
- Healthy as defined by:
- 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...
You likely can't join if
- people to whom any of the following applies will be excluded from the study:
- 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...
- Positive pregnancy test or lactating female subject.
See the full eligibility criteria
- \- people must meet all of the following criteria to be included in the study:
- 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.
- Healthy as defined by:
- 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...
- Female people of non-childbearing potential must be:
- post-menopausal with confirmation by documented follicle-stimulating hormone (FSH) test; or
- surgically sterile .
- Female people of childbearing potential who are sexually active with a non-sterile male partner must be willing to use an acceptable contraceptive methods throughout the study and for 30 days after the implant is...
- Male people who are not vasectomized for at least 3 months prior to implant insertion and who are sexually active with a female partner of childbearing potential must be willing to use an acceptable contraceptive...
- people to whom any of the following applies will be excluded from the study:
- 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...
- Positive pregnancy test or lactating female subject.
- Positive urine drug screen, urine cotinine test, or alcohol breath test.
- Known medically significant intolerance or allergic reactions to nalmefene or to ethylene vinyl acetate
- Hypersensitivity to lidocaine or other local anesthetics of the amide type, epinephrine, antiseptic solution
- Clinically significant ECG abnormalities or vital signs abnormalities
- History of drug use within 1 year prior to screening or recreational use of marijuana within 1 month
- History of alcohol abuse within 1 year prior to screening
- Use of medications for the timeframes specified below:
- depot injection or implant within 3 months prior to implant insertion;
- any drug known to induce hepatic drug metabolism within 30 days prior to implant insertion;
- prescription medications within 14 days prior to implant insertion;
- any vaccine within 14 days prior to implant insertion;
- over-the-counter medications and natural health products within 7 days prior to implant insertion
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to implant insertion,
- Donation of plasma within 7 days prior to dosing or donation or
- Intolerant to venipuncture and/or have difficulty with venous access.
- History of wound healing problems.
- Lymphedema, scarring, or tattoos on his/her inner upper arms within 2 months prior to screening or a history of keloid scarring.
- Any dermatologic disorder, including cancer, that precludes the safety of the implant
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Morrisville, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Morrisville, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.