The Safety and Dose Response to Single Anal Doses of NRL001

Norgine44 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Faecal Incontinence

Interventions

Perianal NRL001 Gel 3 strengthsDRUG

A single application of 0.3%, 1.0%, 3.0% NRL001 gel in stepwise dose ascending fashion.

Intraanal NRL001 Gel 2 strengthsDRUG

A single application of 3.0% or 1.0% Gel

Intrarectal NRL001 GelDRUG

A single application of 1.0% Gel

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * No previous history of ano-rectal conditions/diseases. * No history of heart disease. * 18 to 75 years of age. * Males and females but pre-menopausal females of child bearing potential must be using adequate contraceptive methods and have a negative pregnancy test before the start of the study. Exclusion Criteria: * Use of medication in the last 30 days with vasodilatory activity. * Use of any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in Part A, Part B or Part C of NRL001-01/2002(HV) * Regular intake of more than 21 units of alcohol per week. * Pregnant females. * Breast feeding mothers. * Presence of concomitant gastrointestinal diseases or disorders, such as significant abdominal symptoms and haemorrhoids but also any significant organ (e.g. renal, hepatic or cardiac)dysfunction. * Volunteers whom the investigator feels would not be compliant with the requirements of the trial.

Locations (1)

University Hospital - Queens Medical Centre

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Mean anal resting pressure

Mean anal resting pressure (MARP) was recorded using anal manometric catheter

Time frame: Six hours at visit 2

Secondary Outcomes

Blood pressure (mmHg)

Blood pressure was measured before the application of the trial medication and then every 30 minutes for the first 2 hours after application, plus 2 hourly for the remaining follow-up period.

Time frame: Six hours at visit 2

Pulse rate (beats per minute)

Pulse rate was measured before the application of the trial medication and then every 30 minutes for the first 2 hours after application, plus 2 hourly for the remaining follow-up period.

Time frame: Six hours at visit 2

Data from ClinicalTrials.gov

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