NCT06593743

The Safety and Dose Response to Single Anal Doses of NRL001

Proof of Concept Study in Healthy Volunteers to Investigate the Safety and Dose Response to a Single Dose (0.3%,1% or 3%) of Methoxamine (NRL001)applied to the Anus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics of NRL001 and subject safety are also examined.

Detailed description

This is a single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics of NRL001 and subject safety are also examined. The study consists of four parts, which evaluate different NRL001 concentrations and sites of application. Treatments consist of a single local application of either 0.3%, 1% or 3% w/w NRL001 gel applied peri-anally, of either 1% or 3% w/w NRL001 gel applied intra-anally, or 1% w/w NRL001 administered rectally. In addition, a 10 mg NRL001-containing suppository applied to the rectum is assessed.

Conditions

• Faecal Incontinence

Interventions

Type	Name	Description
DRUG	Perianal NRL001 Gel 3 strengths	A single application of 0.3%, 1.0%, 3.0% NRL001 gel in stepwise dose ascending fashion.
DRUG	Intraanal NRL001 Gel 2 strengths	A single application of 3.0% or 1.0% Gel
DRUG	Intrarectal NRL001 Gel	A single application of 1.0% Gel
DRUG	NRL001: 10mg suppository	NRL001 10mg suppository applied to rectum.

Timeline

• Start date: 2002-12-01
• Primary completion: 2004-07-01
• Completion: 2013-11-12
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: United Kingdom