NCT03874130

Scopolamine in Healthy Volunteers

Open-label, Dose-escalating, Non-randomized, Single-Center Study to Determine the Safety and Pharmacokinetic Profiles of Scopolamine in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Repurposed Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	Scopolamine	IV Scopolamine

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2019-03-14
• Last updated: 2020-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study