NCT05164367

Pharmacokinetics of Atropine Oral Gel

Single-Dose Pharmacokinetics of Atropine Oral Gel in Healthy Adults

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the single-dose pharmacokinetics of atropine gel formulation after topical administration in the oral cavity of healthy adults.

Detailed description

This study is a single-dose, single-center, open-label study of the pharmacokinetics of atropine gel (0.01% w/w) after topical oral administration in healthy adults. Study participants will be recruited by Drs. Murphy, Darro, and Yellepeddi at the Center for Clinical and Translation Science (CCTS), University of Utah. Participants who meet eligibility criteria will be recruited in the study after signing informed consent. Each of the 10 participants will receive 1 gram of atropine gel (0.01% w/w) containing 0.1 mg atropine via self-administration of gel into the oral cavity. Dr. Yellepeddi is a licensed pharmacist in the State of Utah and will train subjects in the administration of atropine gel in the oral cavity. A series of timed blood samples (0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours, 7 mL each time point) will be collected in commercial tubes, and plasma will be separated by centrifugation. The plasma samples will be stored frozen until further analysis by the Center for Human Toxicology (CHT), University of Utah.

Conditions

• Cerebral Palsy
• Sialorrhea

Interventions

Type	Name	Description
DRUG	Atropine sulfate gel (0.01%)	A research nurse will measure 1 gram of gel using a calibrated measuring spoon and will provide it to the participant for self-administration.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-06-30
• Completion: 2024-12-10
• First posted: 2021-12-20
• Last updated: 2024-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study