Status:
COMPLETED
Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers
Lead Sponsor:
Norgine
Conditions:
Fecal Incontinence
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.
Eligibility Criteria
Inclusion
- IN.1) sex: male and female (non-child-bearing potential or using medically adequate contraception
- IN.2) race: Caucasian
- IN.3) BW: 50 - 100 kg
- IN.4) BMI: 20 - 28 kg.m-2
- IN.5) age: 21 - 50 years
- IN.6) type: healthy on the basis of specified criteria evaluated at the screening visit
- IN.7) willing and able to provide informed consent
Exclusion
- General
- EX.1) Previous participation in the trial
- EX.2) Participant in any other trial during the last 90 days
- EX.3) Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
- EX.4) History of any clinically relevant allergy (including hypersensitivity to the trial medications)
- EX.5) Presence of acute or chronic infection
- EX.6) Presence or history of any relevant co-morbidity
- EX.7) Resting systolic blood pressure \> 140 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
- EX.8) Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular
- EX.9) Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
- EX.10) Positive serology for HBsAg, anti HBc and anti HCV
- EX.11) Positive HIV test
- EX.12) Positive alcohol or urine drug test on recruitment (and upon admission)
- EX.13) History of alcohol and/or drug abuse and/or daily use of \> 30 gr alcohol
- EX.14) Smoking more than 15 cigarettes/day or equivalent of other tobacco products
- EX.15) Use of prohibited medication
- EX.16) Suspicion or evidence that the subject is not trustworthy and reliable
- EX.17) Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard
- General - all females
- EX.18) Positive pregnancy test
- EX.19) Lactating
- EX.20) Not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods \[condom, diaphragm with spermicidal gel\] should be used in addition).
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01406925
Start Date
April 1 2007
End Date
June 1 2007
Last Update
August 1 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital MHAPT Zaritza Johanna
Sofia, Bulgaria