Fecal IncontinencePhase 1NCT01099670
Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of 7.5, 10, 12.5 or 15 mg NRL001 in a 2 g Suppository for 14 Days
A Phase 1 study testing NRL001 in people with Fecal Incontinence, run by Norgine at 1 site in United Kingdom.
Trial summary
Healthy subjects will receive NRL001 or placebo once daily for 14 days. The four treatment groups, shown below, will each consist of 12 subjects: Group 1; Nine subjects will receive a dose of 7.5 mg NRL001 in a 2 g suppository and three will receive matching placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- NRL001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Jun 2010
- 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
- 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, an exercise stress test and electrocardiograms [ECGs] at screening) aged 18-45 years.
- Non-smokers from three months before receiving the 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.
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- 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 one year and confirmed by serum FSH at screening), surgically sterile, practising true sexual abstinence, or must use two highly effective methods of contraception as follows throughout the study until after post study physical examination: contraceptive implants, injectables, oral contraceptives, some intrauterine devices (IUDs), vasectomised partner and / 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 childbearing potential must have a negative pregnancy test at screening (β HCG) and at check-in.
- 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 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.
Who cannot join
- Volunteers will be excluded if they fulfil any of the following criteria:
- 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 clinically significant ano-rectal conditions as judged by the Investigator, clinically significant latex allergy or clinically significant drug allergy.
- Presence of any ECG abnormalities (during rest or during the exercise stress test).
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- Pregnant or lactating females.
- Laboratory values at screening which are deemed to be clinically significant according to Bio-Kinetic Europe Ltd 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 any time during the study, except as required by this protocol.
- Strenuous exercise during study confinement and one week prior to dosing (with the exception of the screening exercise stress test).
- Consumption of alcoholic beverages within 24 hours of confinement. Abstinence is required during study confinement.
- Consumption of xanthine-containing products within 24 hours of confinement 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 Double-blind, Placebo-controlled, Randomised, Parallel-group, Dose-escalating, Repeat Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of the Once Daily Rectal Application of 7.5, 10, 12.5 or 15 mg NRL001 in a 2 g Suppository for 14 Days
Healthy subjects will receive NRL001 or placebo once daily for 14 days. The four treatment groups, shown below, will each consist of 12 subjects:
Group 1; Nine subjects will receive a dose of 7.5 mg NRL001 in a 2 g suppository and three will receive matching placebo.
Read more
Group 2; Nine subjects will receive a dose of 10 mg NRL001 in a 2 g suppository and three will receive matching placebo.
Group 3; Nine subjects will receive a daily dose of 12.5 mg NRL001 in a 2 g suppository and three will receive matching placebo.
Group 4; Nine subjects will receive a daily dose of 15 mg NRL001 in a 2 g suppository and three will receive matching placebo.
The dosing of each group will be completed prior to the next group being dosed. Dose escalation will be dependent on a positive assessment of the safety profile of the preceding group by the Safety Monitoring Board.
The pharmacokinetics of NRL001 will be determined on Days 1, 7 and 14. Pharmacodynamics will be examined using a three lead Holter monitor at screening and at intervals throughout the study period. Adverse events, vital signs, ECGs and clinical laboratory parameters will be collected, tabulated, reviewed and recorded throughout the study.
- Conditions
- Fecal Incontinence
- Being tested
- NRL001, Placebo
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRL001Drug
Rectal suppository Placebo
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 7.5 mg NRL001 | Experimental | Nine subjects will receive 7.5 mg NRL001 in a 2 g suppository; three will receive matching placebo. Receives: Drug: NRL001; Drug: Placebo |
| 10 mg NRL001 | Experimental | Nine subjects will receive 10 mg NRL001 in a 2 g suppository; three will receive matching placebo. Receives: Drug: NRL001; Drug: Placebo |
| 12.5 mg NRL001 | Experimental | Nine subjects will receive 12.5 mg NRL001 in a 2 g suppository; three will receive matching placebo. Receives: Drug: NRL001; Drug: Placebo |
| 15 mg NRL001 | Experimental | Nine subjects will receive 15 mg NRL001 in a 2 g suppository; three will receive matching placebo. Receives: Drug: NRL001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state pharmacokinetics of NRL001
Measured: 14 days
Secondary outcomes (2)
Pharmacodynamic effects of NRL001
Measured: 14 days
Safety will be assessed by recording adverse events (AEs), vital signs, 12-lead ECG, physical examinations and clinical laboratory tests.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJun 2010
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 Fecal 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Bell, MRCGP MFPM, Principal investigator, Bio-Kinetic Europe, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099670
- Sponsor's protocol ID
- NRL001-01/2009 (SURD)
- Other IDs
- 2009-017473-37, 2009
- Status last verified
- Dec 2010
- First submitted
- 15 Feb 2010
- Last updated
- 24 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bell D, Duffin A, Jacobs A, Pediconi C, Gruss HJ. A double-blind, placebo-controlled, randomised, parallel-group, dose-escalating, repeat dose study in healthy volunteers to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetics of the once daily rectal application of NRL001 suppositories for 14 days. Colorectal Dis. 2014 Mar;16 Suppl 1:36-50. doi: 10.1111/codi.12544.
PubMed 24499495
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomised, Parallel-group, Dose-escalating, Repeat Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of the Once Daily Rectal Application of 7.5, 10, 12.5 or 15 mg NRL001 in a 2 g Suppository for 14 Days
- ClinicalTrials.gov ID
- NCT01099670
- Acronym / sponsor ID
- NRL001-01/2009 (SURD)
- Conditions
- Fecal Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 Apr 2010 (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.
Healthy subjects will receive NRL001 or placebo once daily for 14 days. The four treatment groups, shown below, will each consist of 12 subjects:
Group 1; Nine subjects will receive a dose of 7.5 mg NRL001 in a 2 g suppository and three will receive matching placebo.
Group 2; Nine subjects will receive a dose of 10 mg NRL001 in a 2 g suppository and three will receive matching placebo.
Group 3; Nine subjects will receive a daily dose of 12.5 mg NRL001 in a 2 g suppository and three will receive matching placebo.
Group 4; Nine subjects will receive a daily dose of 15 mg NRL001 in a 2 g suppository and three will receive matching placebo.
The dosing of each group will be completed prior to the next group being dosed. Dose escalation will be dependent on a positive assessment of the safety profile of the preceding group by the Safety Monitoring Board.
The pharmacokinetics of NRL001 will be determined on Days 1, 7 and 14. Pharmacodynamics will be examined using a three lead Holter monitor at screening and at intervals throughout the study period. Adverse events, vital signs, ECGs and clinical laboratory parameters will be collected, tabulated, reviewed and recorded throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 7.5 mg NRL001 | Experimental | Drug: NRL001, Drug: PlaceboNine subjects will receive 7.5 mg NRL001 in a 2 g suppository; three will receive matching placebo. |
| 10 mg NRL001 | Experimental | Drug: NRL001, Drug: PlaceboNine subjects will receive 10 mg NRL001 in a 2 g suppository; three will receive matching placebo. |
| 12.5 mg NRL001 | Experimental | Drug: NRL001, Drug: PlaceboNine subjects will receive 12.5 mg NRL001 in a 2 g suppository; three will receive matching placebo. |
| 15 mg NRL001 | Experimental | Drug: NRL001, Drug: PlaceboNine subjects will receive 15 mg NRL001 in a 2 g suppository; three will receive matching placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy adult male or female volunteers (as determined by medical history, physical examination, laboratory test values, vital signs, an exercise stress test and electrocardiograms [ECGs] at screening) aged 18-45 years.
- Non-smokers from three months before receiving the 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 (17 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 clinically significant ano-rectal conditions as judged by the Investigator, 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 |
|---|---|---|
| NRL001Rectal suppository Placebo | Drug | 10 mg NRL001, 12.5 mg NRL001, 15 mg NRL001, 7.5 mg NRL001 |
| PlaceboPlacebo | Drug | 10 mg NRL001, 12.5 mg NRL001, 15 mg NRL001, 7.5 mg NRL001 |
Primary outcome
Steady state pharmacokinetics of NRL001
Time frame: 14 days
2 secondary outcomes
Pharmacodynamic effects of NRL001
Time frame: 14 days
Safety will be assessed by recording adverse events (AEs), vital signs, 12-lead ECG, physical examinations and clinical laboratory tests.
Time frame: 14 days
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 24 Dec 2010.
- Derived from this study: PubMed 24499495Bell D, Duffin A, Jacobs A, Pediconi C, Gruss HJ. A double-blind, placebo-controlled, randomised, parallel-group, dose-escalating, repeat dose study in healthy volunteers to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetics of the once daily rectal application of NRL001 suppositories for 14 days. Colorectal Dis. 2014 Mar;16 Suppl 1:36-50. doi: 10.1111/codi.12544.
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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.
David Bell, MRCGP MFPM principal investigator
Bio-Kinetic 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 Fecal 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 14 inclusion and 17 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 24 Dec 2010. 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?
Steady state pharmacokinetics of NRL001 (time frame: 14 days). 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 NCT01099670, 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 24 Dec 2010.