NCT01099683

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DRUG	NRL001	Single rectal administration of 2 mg NRL001 in a 2 g suppository
DRUG	Placebo	All subjects will receive rectal suppository containing placebo

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-04-07
• Last updated: 2010-12-24

Locations

1 site across 1 country: United Kingdom