The Safety and Dose Response to Single Anal Doses of NRL001

Norgine

Status and phase: Completed; Phase 1

Conditions: Faecal Incontinence

Treatments: Drug: NRL001: 10mg suppository; Drug: Perianal NRL001 Gel 3 strengths; Drug: Intrarectal NRL001 Gel; Drug: Intraanal NRL001 Gel 2 strengths

Study type: Interventional

Funder types: Industry

Identifiers

NCT06593743

NRL001-01/2002 (HV)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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44 participants in 4 patient groups

Perianal NRL001 Gel 3 strengths

Experimental group

Description:

A single peri-anal application of NRL001 0.3%, 1%, 3% gel in stepwise dose ascending fashion.

Treatment:

Drug: Perianal NRL001 Gel 3 strengths

Intraanal NRL001 Gel 2 strengths

Experimental group

Description:

A single intra-anal application of 3% or 1% NRL001 gel.

Treatment:

Drug: Intraanal NRL001 Gel 2 strengths

Intrarectal NRL001 Gel

Experimental group

Description:

A single intra-rectal application of 1% NRL001 gel.

Treatment:

Drug: Intrarectal NRL001 Gel

NRL001: 10mg suppository

Experimental group

Description:

One 10mg NRL001 suppository applied to rectum.

Treatment:

Drug: NRL001: 10mg suppository