Status:
COMPLETED
Safety and Tolerability of the Twice Daily Intra-anal Application of NRL001 Cream for 14 Days
Lead Sponsor:
Norgine
Conditions:
Faecal Incontinence
Eligibility:
All Genders
35-60 years
Phase:
PHASE1
Brief Summary
The study is being conducted to evaluate the safety and tolerability after single and repeated twice daily intra-anal applications of 1mL NRL001 cream in stepwise increasing concentrations.
Detailed Description
Single-centre, randomised, placebo-controlled, double-blind, repeated dose study in healthy male and female volunteers, comprising up to six sequential dose groups receiving 1 mL doses of an investiga...
Eligibility Criteria
Inclusion
- Males or females (only females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
- Caucasian
- 35 to 60 years of age (included)
- BMI: between 22 and 26 kg.m-2
- BW: between 50 and 100 kg
- Willing and able to provide written informed consent
Exclusion
- General - all subjects
- Previous participation in the trial
- Participation in any other trial during the last 90 days
- Donation of blood or plasma within the last 90 days before recruitment
- History of any clinically relevant allergy
- Presence of acute or chronic infection
- Presence or history of any relevant medical condition or disease (as evaluated on the basis of medical history, physical examination, recumbent and standing blood pressure, treadmill ergometry, clinical laboratory tests \[haematology, clinical chemistry, urinalysis, serology\])
- Presence or history of migraine, frequent headaches, Raynaud phenomenon, urinary urge, signs and symptoms of prostatism
- Presence or history of regular/habitual diarrhoea or constipation; previous anal surgery or trauma, anal fissures, rectal disorders
- Resting systolic blood pressure \> 145 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
- Positive treadmill ergometry test
- Resting pulse (PR) or electrocardiographic heart rate (HR) \< 55 bpm
- ECG: AV-block (AV-block grade I included), QT \> 480 msec, QTc \> 450 msec, sick-sinus syndrome
- Positive hepatitis (HBs-Ag or HBc-Ab, HCV-Ab) or HIV serology test
- History of alcohol or (social) drug abuse
- Positive alcohol or urine drug test
- Daily consumption of \> 30 g alcohol
- Smoking more than 15 cigarettes/day or equivalent of other tobacco products
- Use of prohibited medication
- Suspicion or evidence that the subject is not reliable
- Suspicion or evidence that the subject is not able to make a free consent or to understand the information detailed in the Subject Information sheet.
- All females
- Positive pregnancy test
- Lactating
- Premenopausal women : not using contraception which is judged adequate and sufficient in the opinion of the clinical investigator
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06593730
Start Date
August 1 2007
End Date
September 1 2007
Last Update
September 19 2024
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