The Safety and Dose Response to Single Anal Doses of NRL001 (NCT06593743) | Clinical Trial Compass
CompletedPhase 1
The Safety and Dose Response to Single Anal Doses of NRL001
United Kingdom44 participantsStarted 2002-12
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.