Clinical Trial

Scopolamine in Healthy Volunteers

Study Description

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Scopolamine

IV Scopolamine

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03874130

ParticipAid ID

aM8XRe