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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.
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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.
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40 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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