Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers

• Status: Completed
• Trial end date: 2022-04-11
• Target enrollment: 0
• Participant gender: All

Summary

The study consists of two Phases with the first phase (Pilot Phase) divided into two sub phases.

In each study phase, subjects will be admitted to the clinical unit from 10 hours prior to the first drug administration on Day -1 until approximately 12 hours following the last study drug administration. Screening of alcohol and drugs of abuse will be performed before the first study drug administration. For female subjects, a pregnancy test will be performed before the first drug administration. Clinical nasal irritation rating and the Brief Smell Identification Test will be performed at screening.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pocket Naloxone Corp
• Treatments: Naloxone

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form (ICF)

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Healthy adult male or female

4. If female, meets 1 of the following criteria:

1. Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:

• Abstinence from heterosexual intercourse from the first study drug administration through to at least 30 days after the last dose of the study drug

• 1 of the following highly-effective contraceptive methods, used from at least 28 days prior to the first study drug administration through to at least 30 days after the last dose of the study drug: Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch) Intrauterine device (with or without hormones) Male partner vasectomized at least 6 months prior to the first study drug administration

• The following effective contraceptive method, used from the first study drug administration through to at least 30 days after the last dose of the study drug:

Male condom with diaphragm/cervical cap plus spermicide Or

2. Male partner has had a vasectomy less than 6 months prior to dosing, and the female subject agrees to use an additional acceptable contraceptive method from the first study drug administration through to at least 30 days after the last dose of the study drug Or

3. Is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study drug administration)

5. Aged at least 18 years but not older than 55 years

6. Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively

7. Non- or ex-smoker (An ex smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration)

8. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs), ECG, and/or nasal cavity examination, as determined by an investigator

Exclusion Criteria:

1. Female who is lactating at screening

2. Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration

3. Seated blood pressure higher than 140/90 mmHg at screening or prior to the first study drug administration

4. History of significant hypersensitivity to naloxone or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs

5. Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects

6. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease

7. Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment

8. Any intranasal conditions including nostril piercing, abnormal nasal anatomy, nasal symptoms (i.e., blocked and/or runny nose, nasal polyps, etc.), or having a product sprayed into the nasal cavity prior to drug administration

9. Current or recent upper respiratory tract infection (within 28 days before the first study drug administration)

10. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)

11. Any clinically significant illness in the 28 days prior to the first study drug administration

12. Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the participant as healthy

13. Any history of tuberculosis

14. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration

15. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus antibody tests

16. Any other clinically significant abnormalities at screening that would, in the opinion of an investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data

17. Inclusion in a previous group for this clinical study (for Phase 2 only)

18. Intake of naloxone in the 28 days prior to the first study drug administration

19. Intake of an Investigational Product (IP) in the 28 days prior to the first study drug administration

20. Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration

21. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration