Major Depressive Disorder (MDD) Clinical Trial
Official title:
Open-label, Dose-escalating, Non-randomized, Single-Center Study to Determine the Safety and Pharmacokinetic Profiles of Scopolamine in Healthy Volunteers
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 160 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.
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 10,13, and 14 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 through 16 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, 13
and 14 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 and 15 the dose is "0.6 mg /
0.12 g", delivered in a single dose, and for Cohort 16 the dose is "0.6 mg / 0.12 g", in a
modified excipient formulation, delivered in a single dose.
For Cohort 16 only: Each 0.12 gram of the gel contains 0.6 mg of scopolamine HBr as the
active ingredient along with a modified formulation of excipients sodium citrate, citric
acid, sodium metabisulfite, glycerin, benzalkonium chloride 100, polyvinyl alcohol 18, and
purified water.
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.
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