Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 1 Nalmefene implant

    Drug

    One implant

  • 2 Nalmefene implants

    Drug

    Two Implants

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Cohort 1; 1 ImplantActive comparator 1 intervention
Group B: Cohort 2; 2 ImplantsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Adverse Events (AEs) after implantation with 1 or 2 nalmefene implants.

Time frame
Day 1 up to Week 12 or Week 24
2

Columbia-Suicide Severity Rating Scale (C-SSRS)

Questionnaire

Time frame
Day 1 and Day 2
3

Montgomery-Asberg Depression Rating Scale (MADRS)

Questionnaire

Time frame
Day 1 and Day 2

Secondary outcomes

1

Maximum observed plasma concentration (Cmax) of nalmefene after implantation with 1 or 2 nalmefene implants.

PK blood sample

Time frame
Day 1, 2, 3, 4, Weeks 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 22, 24, 25, 26
2

Area under the concentration curve (AUC) after implantation with 1 or 2 nalmefene implants

PK blood sample

Time frame
Day 1, 2, 3, 4, Weeks 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 22, 24, 25, 26
3

Plasma concertation of nalmefene after implantation with 1 or 2 nalmefene implants

PK blood sample

Time frame
Day 1, 2, 3, 4, Weeks 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 22, 24, 25, 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ReacX Pharmaceuticals, Inc.

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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