Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of a Single Rectal Application of 10 m… (NCT01099683) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of a Single Rectal Application of 10 mg NRL001 in Elderly Subjects
United Kingdom26 participantsStarted 2010-04
Plain-language summary
A total of 26 healthy elderly male and female subjects will receive both 10 mg NRL001 in a 2 g rectal suppository and placebo in this double-blind, cross-over study. The order of treatment will be randomised, with a minimum washout period of 3 days between doses. An end of study assessment will be conducted at least 7 days after administration of the last treatment.
The pharmacokinetics of NRL001 will be determined prior to, and after, dosing. Pharmacodynamics will be examined using a three lead Holter monitor during both treatment periods. Adverse Events, vital signs, ECGs and clinical laboratory parameters will be collected, tabulated, reviewed and recorded throughout the study.
Who can participate
Age range
65 Years
Sex
ALL
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:
Volunteers will be included in the study if they satisfy the following criteria:
* Healthy adult male or female volunteers (as determined by medical history, physical examination, laboratory test values, vital signs and electrocardiograms \[ECGs\] at screening) aged ≥65 years.
* Non-smokers from 3 months before receiving the first dose and for the duration of the study.
* Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2.
* Able and willing to receive rectal treatments.
* Able to voluntarily provide written informed consent to participate in the study.
* Sexually active male volunteers must use condoms with their partners throughout the study and for 90 days after completion of the study in addition to their partner's normal mode of contraception.
* Male volunteers must not donate sperm during the study and for 90 days after completion of the study.
* Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol.
* Female volunteers must be postmenopausal (for at least 1 year, confirmed by FSH testing at screening).
* Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
* The volunteer's primary care physician must confirm that there is nothing in their medical history that would preclude their enrolment into this clinical study.
Exclusion Criteria:
Volunteers will be excluded if they fulfil any of the following criteria:
* Positive…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this was a Phase 1 trial that has already been completed, what were the actual safety and tolerability findings for NRL001 as a rectal application, and would those results be relevant to my situation?
2This study tested only a single dose of NRL001 rectally — does that mean there's still limited information about how safe or effective it might be with repeated use for managing fecal incontinence long-term?
3The trial specifically enrolled elderly subjects — given that this was a small, early-phase safety study, are there now larger or later-phase trials of NRL001 that might give us more complete information before considering it as an option?
4Compared to what this early trial was designed to test, what standard or approved treatments for fecal incontinence might already have a stronger evidence base that we should consider first?
5Since this trial focused on pharmacodynamic and pharmacokinetic measurements rather than symptom relief, does that mean we don't yet have solid evidence about whether NRL001 actually helps with fecal incontinence symptoms?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.