Skip to main content
OpenTrials
Completed

NCT Number: NCT00857467

Study to Investigate Safety and Response to 1 or 2 g Rectal Suppositories Containing 5 or 10 mg NRL001.

This is a healthy volunteer three-way crossover study. A total of 12 subjects will receive three single administrations of 1 g rectal suppositories (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), with a washout period of at least 7 days between dosings. A further 12 subjects will receive three single administrations of 2 g rectal suppositories (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), again with a 7 day washout period between dosings. The pharmacodynamic response, pharmacokinetics and safety profile will be determined.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of GI Surgery, Nottingham University Hospital

Nottingham, NG7 2UH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No previous history of ano-rectal conditions or diseases
  • No history of cardiovascular disease
  • 18 to 60 years of age
  • Males and females (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 a vasodilatory activity, or use of any medication currently or within the last 30 days which the Investigator believes may affect the study participation or results
  • Use of monoamine oxidase inhibitors presently or within the last 2 weeks before study participation
  • Use of any medication in the last 30 days applied to the anus and/or via the rectum
  • Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last three months which involved being paid a disturbance allowance; having an invasive procedure (e.g. venepuncture >50ml, endoscopy) or exposure to ionising radiation.
  • Regular intake of more than 21 units of alcohol per week
  • History or any evidence of cardiovascular disease including ischaemic heart disease and hypertension (defined on examination: systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 90 mmHg; based on at least two separate readings), peripheral vascular disease or Raynaud's syndrome
  • Presence of diabetes mellitus
  • History or symptoms of thyroid diseases, including hypo- or hyperthyroidism
  • Pregnant or lactating females
  • History of any clinically relevant allergy
  • 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 comply with the requirements of the trial
  • Volunteers who have been exposed to more than 5 mSv of ionising radiation in the last 12 months.

Treatment and study plan

NRL001

Drug

Subjects receive single doses of 5 mg NRL001, 10 mg NRL001 and placebo in a 1 g rectal suppository, with a 7-day washout period between dosing.

Primary outcomes

  1. Change in MARP after a single dose

    Time frame: 6 hours

Secondary outcomes

  1. Pharmacokinetic plasma assessment to determine systemic uptake

    Time frame: 6 hours

  2. Adverse events

    Time frame: 6 hours

  3. Cardiovascular parameters; heart rate and blood pressure

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

Norgine

Industry

Registry information

Official study title

Randomised, Double-blind, Single Dose, Three-way, Cross-over Study to Investigate the Safety and Response to 1g or 2g Rectal Suppositories Containing 5 mg or 10 mg 1R,2S-methoxamine Hydrochloride [NRL001] or Matching Placebo

Important dates

Study start
2009
Primary completion
2009
First posted
Mar 6, 2009
Registry last updated
Dec 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.