Scopolamine in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT03874130|
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 22, 2019
This single-site clinical trial is an open-label study to identify the safety and pharmacokinetics of DPI-386 Nasal Gel (intranasal scopolamine gel) and IV Scopolamine. The study will require subjects to receive either multiple doses of 0.2 mg or a single dose of 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, or 1.2 mg of DPI-386 Nasal Gel or 0.4 mg/mL IV Scopolamine per the assigned treatment cohort. Multiple PK blood draws will be collected dependent on cohort assignment. Vital signs and ECGs will be collected. No efficacy will be tested. Subjects will be monitored for at least eight hours after the final dose. There could be up to 120 subjects enrolled stratified equally by gender.
Screening will not occur until after subjects have signed the informed consent form (ICF). Screening will include hematology, biochemistry, urinalysis, alcohol and drug screen, physical examination, including vital signs and ECG, and review of medical history by the PI or qualified designee, serum pregnancy test as applicable, and agreement to adhere to the study lifestyle requirements.
Subject data will be recorded in the source documents and appropriate eCRF.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder (MDD)||Drug: Scopolamine||Phase 1|
The investigational product is a combination product comprised of: (a) a vial prefilled with DPI-386 Nasal Gel, and (b) a nasal gel pump attached to the vial during the manufacturing process. For Cohorts 1 through 4, 9 through 10, and 13 each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr as the active ingredient along with the excipients sodium citrate, citric acid, sodium metabisulfite, glycerin, benzalkonium chloride, polyvinyl alcohol and purified water. For Cohorts 1 through 4, 9, 10 and 13 each vial of DPI-386 Nasal Gel is a multi-dose product, sufficient for six individual doses. Each pumping action is designed to deliver a single 0.12 g dose. The DPI-386 Nasal Gel for Cohorts 1 through 4 and 13 is formulated to contain 0.2 mg scopolamine HBr per 0.12 g dose, with each dose therefore described as "0.2 mg / 0.12 g". For Cohort 6 the dose is "0.8 mg / 0.12 g", and for cohort 7 the dose is "1.0 mg / 0.12 g", and for Cohort 8 the dose is "1.2 mg / 0.12 g", and for Cohort 11 the dose is "0.4 mg / 0.12 g", and for Cohort 12 the dose is "0.6 mg / 0.12 g", delivered in a single dose.
Each vial/pump unit must be primed by research staff prior to first dose delivery. Subjects will self-administer the drug under guidance from the study staff.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Dose-escalating, Non-randomized, Single-Center Study to Determine the Safety and Pharmacokinetic Profiles of Scopolamine in Healthy Volunteers|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Active Comparator: Scopolamine
0.2 mg scopolamine HBr per dose
Other Name: scopolamine HBr
Active Comparator: IV Scopolamine
4.0 μg/kg; 15 minute IV infusion
Other Name: scopolamine HBr
- Describe the safety of Scopolamine HBr [ Time Frame: The duration of participation for each subject will be approximately two weeks. ]Safety will be evaluated in terms of adverse events. Number of patients that report events of special interest as listed in the protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874130
|Contact: Laurie Mellottemail@example.com|
|United States, California|
|Collaborative Neuroscience Network, LLC||Recruiting|
|Long Beach, California, United States, 90806|
|Contact: Jay Saifuki 562-304-1740|