NCT06593743

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
9.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
9.3 years until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

June 9, 2015

Last Update Submit

September 10, 2024

Conditions

Faecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • Mean anal resting pressure

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

    Six hours at visit 2

Secondary Outcomes (2)

  • Blood pressure (mmHg)

    Six hours at visit 2

  • Pulse rate (beats per minute)

    Six hours at visit 2

Study Arms (4)

Perianal NRL001 Gel 3 strengths

EXPERIMENTAL

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

Drug: Perianal NRL001 Gel 3 strengths

Intraanal NRL001 Gel 2 strengths

EXPERIMENTAL

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

Drug: Intraanal NRL001 Gel 2 strengths

Intrarectal NRL001 Gel

EXPERIMENTAL

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

Drug: Intrarectal NRL001 Gel

NRL001: 10mg suppository

EXPERIMENTAL

One 10mg NRL001 suppository applied to rectum.

Drug: NRL001: 10mg suppository

Interventions

Perianal NRL001 Gel 3 strengthsDRUG

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

Also known as: methoxamine gel 0.3%, 1.0%, 3.0%
Perianal NRL001 Gel 3 strengths
Intraanal NRL001 Gel 2 strengthsDRUG

A single application of 3.0% or 1.0% Gel

Also known as: methoxamine gel 3.0%, 1.0%
Intraanal NRL001 Gel 2 strengths
Intrarectal NRL001 GelDRUG

A single application of 1.0% Gel

Also known as: methoxamine gel 1.0%
Intrarectal NRL001 Gel
NRL001: 10mg suppositoryDRUG

NRL001 10mg suppository applied to rectum.

Also known as: methoxamine suppository
NRL001: 10mg suppository

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No previous history of ano-rectal conditions/diseases.
  • No history of heart disease.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital - Queens Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Encopresis

Interventions

Suppositories

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Hans-Jürgen Gruss, MD

    Norgine

    STUDY DIRECTOR

  • John H Scholefield, MD

    University Hospital - Queens Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2015

First Posted

September 19, 2024

Study Start

December 1, 2002

Primary Completion

July 1, 2004

Study Completion

November 12, 2013

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

GB(1)