← Back to Search

Opioid Receptor Antagonist

Sequence 2 for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Tharimmune Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject body weight ≤ 120 kg, with a BMI within of 18-30 kg/m2

Subject age between 18 to 55 years old.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 days

Awards & highlights

Study Summary

This trial is studying the effects of a buccal formulation of Nalmefene 16 mg (a medication) compared to a 1 mg intravenous dose of Nalmefene injection.

Who is the study for?

This trial is for healthy adults weighing less than 120 kg with a BMI of 18-30. Participants must be aged between 18 to 55 years, able to give written consent, and complete the study including follow-up.Check my eligibility

What is being tested?

The study tests how much of the drug Nalmefene is absorbed into the bloodstream when taken as a buccal (cheek) formulation compared to an intravenous injection. It's a single-dose study with two different ways of taking the medication and a break in between doses.See study design

What are the potential side effects?

As this trial involves healthy subjects and details on side effects are not provided, typical side effects may include reactions at the site of administration, nausea, dizziness or headaches. Specific side effects will depend on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I weigh 120 kg or less and my BMI is between 18-30.

Select...

I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under the Plasma Concentration Versus Time Curve (AUC) of Nalmefene

Secondary outcome measures

Number of Participants With Treatment-Related Adverse Events

Side effects data

From 2010 Phase 3 trial • 598 Patients • NCT00811720

28%

Dizziness

27%

Nausea

18%

Fatigue

12%

Nasopharyngitis

12%

Headache

11%

Sleep disorder

10%

Insomnia

Vomiting

Hyperhidrosis

Alcoholism

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Nalmefene 18.06 mg

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sequence 2Experimental Treatment1 Intervention

A 1 mg intravenous dose of nalmefene injection, and a buccal formulation of Nalmefene 16 mg with a least 7 days washout period between dose

Group II: Sequence 1Experimental Treatment1 Intervention

A buccal formulation of Nalmefene 16 mg and a 1 mg intravenous dose of nalmefene injection, with a least 7 days washout period between dose

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nalmefene

2016

Completed Phase 3

~2250

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Tharimmune IncLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for individuals to participate in this clinical trial?

"- Body weight of ≤120 kg"

Answered by AI

What is the level of patient safety associated with Sequence 2?

"Based on the assessment made by our team at Power, Sequence 2 has been assigned a safety rating of 1. This determination is due to its Phase 1 trial status, which indicates limited available data supporting both safety and efficacy."

Answered by AI

What is the current number of individuals being enrolled in this research investigation?

"Indeed, the information available on clinicaltrials.gov indicates that this study is currently actively seeking eligible participants. The trial was initially posted on January 26th, 2024 and has been recently updated as of the same date. In total, the trial aims to recruit 20 patients from a single site."

Answered by AI

Is the inclusion criteria for this study open to individuals aged 75 years and above?

"Candidates aged 18 to below 55 years are eligible for participation in this study."

Answered by AI

Are participants currently being enrolled for this research study?

"Indeed, according to the information available on clinicaltrials.gov, this trial is currently open for patient enrollment. The initial posting was made on January 26th, 2024 and the most recent update also occurred on that same date."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Evaluation of The Absolute Bioavailability of TH104

2024. "An Evaluation of The Absolute Bioavailability of TH104". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06198686.

All > Paid Studies Las Vegas