Intra-anal Oxymetazoline in Healthy Adult Volunteers

Fecal Incontinence Clinical Trial

Official title: A Phase I, Open-Label, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intra-anal Application of Topical Oxymetazoline Gel in Healthy Adult Volunteers

Status Active, not recruiting

Clinical Trial Summary

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. A total of 32 healthy male and female subjects will be enrolled to receive either Topical Oxymetazoline 1 mg (Cohort A, n=16), 5 mg (Cohort B, n=8) and 10 mg (Cohort C, n=8) applied intra-anally daily (QD) for 11 consecutive days.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Fecal Incontinence

• NCT number: NCT03529487
• Study type: Interventional
• Source: RDD Pharma Ltd
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 20, 2018
• Completion date: December 1, 2023