Clinical Trial

Intra-Anal Oxymetazoline in Healthy Adult Volunteers

Study Description

Intra-anal Oxymetazoline in Healthy Adult Volunteers

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.

Location

Locations Selected Location

Methods

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

Drug - Oxymetazoline

Oxymetazoline gel applied intra-analy

Additional Information

Official Study 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

Clinical Trial ID

NCT03529487

ParticipAid ID

9b6kOd