Status:
COMPLETED
An Evaluation of The Absolute Bioavailability of TH104
Lead Sponsor:
Tharimmune Inc
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Hepatitis B, Hepatitis C or HIV positive.
- Positive test for drugs of abuse.
- Smoke more than 10 sticks of cigarettes a day, vape more than 20 mg of liquid nicotine a day, or equivalent.
- A history of drug or substance abuse, including alcohol (≥ 7 units per week) within 6 months before dosing (1 unit of alcohol equals approximately ½ pint \[240 mL\] of beer, 1 glass \[125 mL\] of wine, or 1 shot \[25 mL\] of spirit).
- Have taken any medications (including herbal remedies) within 7 days before dosing, with the exception of birth control medications and other medications deemed acceptable by the Investigator.
- Use of any opioid antagonist (e.g., naloxone, naltrexone, nalmefene) in the past.
- Clinically significant illness or injury or hospitalization for any reason within 28 days before dosing.
- Participation in other clinical study involving a marketed or investigational drug within 28 days or 10 half-lives of the drug before dosing, whichever is longer.
- Donation of \> 500 mL of plasma within 14 days before dosing; or donation or loss of whole blood (excluding the amount of blood collected during screening) before dosing as follows:
- 50-300 mL within 28 days,
- 301-500 mL within 42 days, or
- 500 mL within 84 days.
- Any other medical condition or reason that, in the opinion of the Investigator or Research Physician, makes the subject unsuitable to participate in the clinical study.
- Female of childbearing potential having unprotected sexual intercourse with any non-sterile male partner within 14 days before dosing and until 60 days after receiving the last dose; acceptable methods of contraception include:
- double barrier (1 by each partner), and at least 1 of these barriers (condom, cervical cap, diaphragm or sponge) must contain spermicide,
- hormonal (oral, injectable, transdermal, intravaginal or implantable),
- intrauterine contraceptive system,
- surgical (vasectomy or tubal ligation), or
- sexual abstinence.
Key Trial Info
Start Date :
January 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06198686
Start Date
January 26 2024
End Date
November 6 2024
Last Update
April 8 2025
Active Locations (1)
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1
Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States, 89121