NCT00893607

Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum

Proof of Concept Study in Healthy Volunteers to Investigate the Safety and Response to a Single Dose of 10mg Methoxamine (NRL001) Applied Locally Using a Suppository to the Anal Canal or Rectum

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when administered as a slow release suppository applied to the anal canal or rectum. In addition, the pharmacokinetics of NRL001 in plasma, adverse events, and any changes in heart rate or blood pressure were to be assessed.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DRUG	NRL001	10mg NRL001 was administered as a slow release suppository

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-08-01
• Completion: 2007-12-01
• First posted: 2009-05-06
• Last updated: 2009-05-06

Locations

1 site across 1 country: United Kingdom