NCT01406925

Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers

A Randomised, Placebo-controlled, Double-blind, Cross-over Study in Healthy Men and Women to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intra-anal Doses of NRL001 for Three Doses Using a Cream Formulation Relative to a Matched Placebo Formulation for Reference

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DRUG	Placebo control	Placebo cream
DRUG	NRL001 cream	Cream for single-dose intra-anal application

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-05-01
• Completion: 2007-06-01
• First posted: 2011-08-01
• Last updated: 2011-08-01

Locations

1 site across 1 country: Bulgaria