An Evaluation of The Absolute Bioavailability of TH104

NCT06198686 | Completed Phase 1 FDA Drug

• 1 other identifier: TH104-105
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-dose, single-center, open-label, randomized, 2-way crossover study (2 treatments, 2 periods and 2 sequences) of a buccal formulation of Nalmefene 16 mg and a 1 mg intravenous dose of nalmefene injection, with a least 7 days washout period between doses.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  Determine the absolute bioavailability of a buccal dose of TH104

  4 days

Secondary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events

  4 days

Study Arms (2)

Sequence 1

EXPERIMENTAL

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

Drug: Nalmefene

Sequence 2

EXPERIMENTAL

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

Drug: Nalmefene

Interventions

Nalmefene DRUG

Opioid antagonist

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject age between 18 to 55 years old.
• Subject body weight ≤ 120 kg, with a BMI within of 18-30 kg/m2
• Subject is able to complete the clinical study including the follow-up.
• Subject is capable of providing written informed consent.

You may not qualify if:

• Breastfeeding female.
• Positive pregnancy test (female).
• Systolic blood pressure outside 80-140 mm Hg or diastolic blood pressure outside 50-80 mm Hg.
• Bradycardia defined as symptomatic heart rate \< 60 bpm or asymptomatic heart rate \< 55 bpm and tachycardia defined as resting heart rate \> 100 bpm.
• Clinically significant ECG abnormalities.
• QTc \> 450 ms for male and \> 460 ms for female.
• A history of allergies, or any significant adverse reactions, to any medications.
• A history of seizures or convulsions.
• Clinically significant medical, familial, or surgical history of eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, genitourinary, neurological, hematopoietic, lymphatic, endocrine, metabolic, dermatological, musculoskeletal, psychological and/or other major disease or malignancy.
• Family history of sudden cardiac death.
• Clinically significant physical examination finding.
• Clinically significant laboratory abnormalities.
• Hemoglobin \< 12.0 g/dL for male and \< 11.0 g/dL for female at screening.
• Creatinine clearance \<90 mL/m2/min
• Total bilirubin , ALT/AST greater than upper limit of normal, or CPK \> 2 x upper limit of normal.

Sponsors & Collaborators

• Tharimmune Inc: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Interventions

nalmefene

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: January 26, 2024
• Primary Completion: February 11, 2024
• Study Completion: November 6, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)