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The Safety and Dose Response to Single Anal Doses of NRL001

NCT06593743 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Faecal Incontinence

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Hans-Jürgen Gruss, MD · Norgine

  • John H Scholefield, MD · University Hospital - Queens Medical Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2004-07-31
Completion
2013-11-12

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06593743 on ClinicalTrials.gov