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Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of a Single Rectal Application of 10 mg NRL001 in Elderly Subjects

Fecal Incontinence Clinical Trial

Official title:
A Double-blind, Randomised, Placebo-controlled Study in Elderly Subjects to Evaluate the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of a Single Rectal Application of 10 mg NRL001 in a 2 g Suppository

Clinical Trial Summary

A total of 26 healthy elderly male and female subjects will receive both 10 mg NRL001 in a 2 g rectal suppository and placebo in this double-blind, cross-over study. The order of treatment will be randomised, with a minimum washout period of 3 days between doses. An end of study assessment will be conducted at least 7 days after administration of the last treatment.

The pharmacokinetics of NRL001 will be determined prior to, and after, dosing. Pharmacodynamics will be examined using a three lead Holter monitor during both treatment periods. Adverse Events, vital signs, ECGs and clinical laboratory parameters will be collected, tabulated, reviewed and recorded throughout the study.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01099683
Study type Interventional
Source Norgine
Contact
Status Completed
Phase Phase 1
Start date April 2010
Completion date July 2010
View Details
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