Fecal Incontinence
Conditions
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.
Interventions
DRUGPlacebo control
Placebo cream
DRUGNRL001 cream
Cream for single-dose intra-anal application
Sponsors
Norgine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
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 criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of NRL001 | 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC of NRL001 | 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing | — |
| Tolerability of NRL001 | Up to 12 hours post-dosing | Spontaneously reported adverse events will be recorded |
Countries
Bulgaria
Outcome results
None listed