Status:
COMPLETED
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
Lead Sponsor:
Emergent BioSolutions
Conditions:
Opioid Overdose
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
Detailed Description
Based on the intended AP003 product presentation there will be two devices in each carton allowing for administration of a total of 16 mg. This study is designed for subjects to receive naloxone thera...
Eligibility Criteria
Inclusion
- Are able to consent and freely provide informed consent.
- Females and males 18-55 years of age, inclusive.
- Have a body mass index (BMI) less than or equal to 34.0 kg/m2.
- Generally healthy, in the opinion of the Investigator, based on medical history, physical examination, vital signs, screening laboratory assessments and 12-lead ECG evaluation.
- If female:
- Have a negative pregnancy test at Screening (serum pregnancy test) and before dosing at Day -1 (urine pregnancy test)
- Female subjects of non-childbearing potential must be:
- Post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented FSH levels ≥40 mIU/mL; or
- Surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or tubal ligation) at least 3 months prior to dosing.
- Women of childbearing potential who are not planning to be pregnant during the study period and who are using one of the following effective methods of contraception during the study period and for at least 30 days after last study visit:
- Simultaneous use of hormonal contraceptive (e.g. oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device for at least 4 weeks prior to dosing (must agree to use the same contraceptive throughout the study) and condom for the male partner.
- Simultaneous use of diaphragm or cervical cap with spermicide and condom for the male partner, started at least 21 days prior to dosing.
Exclusion
- Subjects planning to become pregnant during the study or currently breastfeeding.
- Any acute condition, in the opinion of the Investigator, that is not fully resolved at least 4 weeks prior to baseline.
- Subject has a deviated septum, previous rhinoplasty, abnormal nasal anatomy, other nasal symptoms (i.e., blocked and/or runny nose), or other nasal surgeries (i.e., polyp removal) within 1 year, or needs to use another nasal spray product during study.
- Subject with current upper respiratory infection (URI) or has had URI within 7 days prior to screening.
- Subject has had an episode of epistaxis within 30 days prior screening or has experienced recurrent episodes of epistaxis within 1 year prior to screening.
- Subject has used any prescription or nonprescription drugs/supplements with increased risk of bleeding within 28 days or 5 half-lives (whichever is longer) or complementary and alternative medicines within 28 days before the first dose of study drug with exception of oral contraceptives. All other prescription medications, over-the-counter, and natural health products within 14 days or 5 half-lives prior to the first dosing.
- Subject is currently participating in another clinical study of an investigational drug or has been dosed with any investigational drug within 30 days or 5 half-lives (whichever is longer) of the compound.
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05377255
Start Date
March 28 2022
End Date
May 10 2022
Last Update
March 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Syneos Health Clinical Research Services
Miami, Florida, United States, 33136