IncontinencePhase 1NCT00850590
Study of Escalating Doses of NRL001 Given in Slow-release Rectal Suppositories of Different Weights
A Phase 1 study testing NRL001 in people with Incontinence, run by Norgine at 1 site in United Kingdom.
Trial summary
Studies investigating single doses of different NRL001 formulations showed formulation-dependent differences in exposure, even though they had similar effects on mean anal resting pressure (MARP). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Incontinence
- What is being tested?
- NRL001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female volunteers (as determined by medical history, physical examination, laboratory test values, vital signs, and electrocardiograms [ECGs] at screening) aged 18-45 years.
- Non-smokers from 3 months of receiving first dose and for the duration of the study.
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Able and willing to receive rectal treatments.
- Able to voluntarily provide written informed consent to participate in 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.
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- Female volunteers must be postmenopausal (for at least one year and confirmed by serum FSH at screening), surgically sterile, practising true sexual abstinence, or use two highly effective methods of contraception as follows throughout the study until after post study physical: contraceptive implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository.
- Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study.
- Females of child bearing potential must have a negative pregnancy test at screening (β-HCG) and prior to each dosing.
- 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 normal mode of contraception.
- Male volunteers must not donate sperm during the study and for 90 days after completion of the study.
- Must be willing to consent to have data entered into The Over Volunteering Prevention System.
- 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.
Who cannot join
- Positive for HIV, hepatitis B, or hepatitis C as demonstrated by the results of testing at screening.
- History or presence of any significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- History or presence of aortic stenosis or hypertrophic cardiomyopathy.
- History or presence of any ano-rectal conditions, clinically significant latex allergy or clinically significant drug allergy.
- Presence of any ECG abnormalities (during rest or during the exercise stress test).
- Pregnant or lactating females.
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- Laboratory values at screening which are >1.5x the upper limit of normal for that parameter or <1.5x the lower limit of normal for that parameter, as applicable, or which are abnormal or deemed to be clinically significant according to Bio-Kinetic Europe Ltds SOPs, unless agreed in advance by the Sponsor's Responsible Medical Officer and the Bio-Kinetic Investigator.
- Current or history of drug or alcohol abuse or a positive drugs of abuse test at screening or check in.
- Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.
- Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
- Any significant illness during the screening period preceding entry into this study.
- Donation of blood or blood products within 90 days prior to study drug administration, or at anytime during the study, except as required by this protocol.
- Strenuous exercise during study conduct and one week prior to dosing (with the exception of the exercise stress test).
- Consumption of alcoholic beverages within 24 hours prior to each dosing. Abstinence is required during study confinement.
- Consumption of xanthine-containing products within 24 hours of each dosing and during study confinement.
- Use of any disallowed concomitant medication including over-the-counter items within 14 days prior to study drug administration until the end of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo-controlled, Double-blind, Dose Escalation Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of Rectal Suppositories Containing Between 5 and 15 mg NRL001 or Matching Placebo for Two Different Sized Suppositories (1 g and 2 g).
Studies investigating single doses of different NRL001 formulations showed formulation-dependent differences in exposure, even though they had similar effects on mean anal resting pressure (MARP). This study is a first step in investigating the hypothesis that a better balance between desired anal effects and undesired systemic effects can be reached with a NRL001-slow release suppository than with previously studied formulations.
To this purpose, single doses of 5 to 15 mg, administered as 1 g and 2 g suppositories, are being investigated with regard to their pharmacokinetics and systemic effects (blood pressure, pulse rate, electrocardiographic heart rate).
- Conditions
- Incontinence
- Being tested
- NRL001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRL001Drug
Four single doses of NRL001 or placebo. NRL001 is administered at lower (5, 7.5 and 10 mg) or higher (10, 12.5 and 15 mg) doses in a slow release rectal suppository weighing either 1 g or 2 g.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | NRL001 at 5, 7.5, and 10 mg administered in a dose escalating manner with placebo in a random position in the sequence. NRL001 is contained in either a 1 g or a 2 g slow release rectal suppository. Receives: Drug: NRL001 |
| High Dose | Experimental | NRL001 at 10, 12.5, and 15 mg administered in a dose escalating manner with placebo in a random position in the sequence. NRL001 is contained in either a 1 g or a 2 g slow release rectal suppository. Receives: Drug: NRL001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of different strengths of NRL001 rectal suppositories
Measured: Up to 36 hours post-dose
Secondary outcomes (2)
Dose-related effects on cardiovascular parameters compared with placebo.
Measured: Up to 36 hours post-dose
To assess the safety and tolerability of NRL001.
Measured: Up to 36 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hans-Jürgen Gruss, MD, Study director, NorgineDavid Bell, MRCGP MFPM, Principal investigator, Biokinetic Europe Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850590
- Sponsor's protocol ID
- NRL001-02/2008 (SUSD)
- Status last verified
- Dec 2009
- First submitted
- 23 Feb 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bell D, Pediconi C, Jacobs A. Randomised clinical trial: study of escalating doses of NRL001 given in rectal suppositories of different weights. Colorectal Dis. 2014 Mar;16 Suppl 1:16-26. doi: 10.1111/codi.12542.
PubMed 24499493
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Double-blind, Dose Escalation Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of Rectal Suppositories Containing Between 5 and 15 mg NRL001 or Matching Placebo for Two Different Sized Suppositories (1 g and 2 g).
- ClinicalTrials.gov ID
- NCT00850590
- Acronym / sponsor ID
- NRL001-02/2008 (SUSD)
- Conditions
- Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies investigating single doses of different NRL001 formulations showed formulation-dependent differences in exposure, even though they had similar effects on mean anal resting pressure (MARP). This study is a first step in investigating the hypothesis that a better balance between desired anal effects and undesired systemic effects can be reached with a NRL001-slow release suppository than with previously studied formulations.
To this purpose, single doses of 5 to 15 mg, administered as 1 g and 2 g suppositories, are being investigated with regard to their pharmacokinetics and systemic effects (blood pressure, pulse rate, electrocardiographic heart rate).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: NRL001NRL001 at 5, 7.5, and 10 mg administered in a dose escalating manner with placebo in a random position in the sequence. NRL001 is contained in either a 1 g or a 2 g slow release rectal suppository. |
| High Dose | Experimental | Drug: NRL001NRL001 at 10, 12.5, and 15 mg administered in a dose escalating manner with placebo in a random position in the sequence. NRL001 is contained in either a 1 g or a 2 g slow release rectal suppository. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy adult male or female volunteers (as determined by medical history, physical examination, laboratory test values, vital signs, and electrocardiograms [ECGs] at screening) aged 18-45 years.
- Non-smokers from 3 months of receiving first dose and for the duration of the study.
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Able and willing to receive rectal treatments.
- Able to voluntarily provide written informed consent to participate in the study.
Key exclusion criteria (16 listed)
- Positive for HIV, hepatitis B, or hepatitis C as demonstrated by the results of testing at screening.
- History or presence of any significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- History or presence of aortic stenosis or hypertrophic cardiomyopathy.
- History or presence of any ano-rectal conditions, clinically significant latex allergy or clinically significant drug allergy.
- Presence of any ECG abnormalities (during rest or during the exercise stress test).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRL001Four single doses of NRL001 or placebo. NRL001 is administered at lower (5, 7.5 and 10 mg) or higher (10, 12.5 and 15 mg) doses in a slow release rectal suppository weighing either 1 g or 2 g. | Drug | High Dose, Low Dose |
Primary outcome
Pharmacokinetics of different strengths of NRL001 rectal suppositories
Time frame: Up to 36 hours post-dose
2 secondary outcomes
Dose-related effects on cardiovascular parameters compared with placebo.
Time frame: Up to 36 hours post-dose
To assess the safety and tolerability of NRL001.
Time frame: Up to 36 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
- Derived from this study: PubMed 24499493Bell D, Pediconi C, Jacobs A. Randomised clinical trial: study of escalating doses of NRL001 given in rectal suppositories of different weights. Colorectal Dis. 2014 Mar;16 Suppl 1:16-26. doi: 10.1111/codi.12542.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Jürgen Gruss, MD study director
Norgine
David Bell, MRCGP MFPM principal investigator
Biokinetic Europe Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NRL001 in people with Incontinence, run by Norgine at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of different strengths of NRL001 rectal suppositories (time frame: Up to 36 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00850590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2009.