Intra-anal Oxymetazoline in Healthy Adult Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Fecal Incontinence
- Type
- Interventional
- Phase
- Phase 1
- Design
- Intervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Description
This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application. The primary objective of this study is to determine the plasma concentrations and PK parameters, as data al...
This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application. The primary objective of this study is to determine the plasma concentrations and PK parameters, as data allows, of oxymetazoline following single and repeated intra-anal application of oxymetazoline gel 1 mg, 5 mg or 10 mg in healthy male and female subjects. The secondary objective of this study is to evaluate the safety and tolerability of repeated intra-anal application of oxymetazoline gel 1 mg, 5 mg or 10 mg in healthy male and female subjects. A total of 32 healthy male and female subjects will be enrolled (16 subjects in the first cohort and 8 subjects in the remaining cohorts) and will be exposed to Topical Oxymetazoline 1 mg, 5 mg or 10 mg applied intra-anally QD for 11 consecutive days.
Tracking Information
- NCT #
- NCT03529487
- Collaborators
- United States Department of Defense
- Spaulding Clinical Research LLC
- Investigators
- Not Provided