Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fecal Incontinence |
Drug: Placebo control Drug: NRL001 cream |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised, Placebo-controlled, Double-blind, Cross-over Study in Healthy Men and Women to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intra-anal Doses of NRL001 for Three Doses Using a Cream Formulation Relative to a Matched Placebo Formulation for Reference |
- Cmax of NRL001 [ Time Frame: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing ] [ Designated as safety issue: No ]
- AUC of NRL001 [ Time Frame: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing ] [ Designated as safety issue: No ]
- Tolerability of NRL001 [ Time Frame: Up to 12 hours post-dosing ] [ Designated as safety issue: No ]Spontaneously reported adverse events will be recorded
| Enrollment: | 12 |
| Study Start Date: | April 2007 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control
Placebo control
|
Drug: Placebo control
Placebo cream
|
|
Experimental: Low dose NRL001
0.5% NRL001 cream
|
Drug: NRL001 cream
Cream for single-dose intra-anal application
|
|
Experimental: Intermediate dose NRL001
0.75% NRL001 cream
|
Drug: NRL001 cream
Cream for single-dose intra-anal application
|
|
Experimental: High dose NRL001
1.0% NRL001 cream
|
Drug: NRL001 cream
Cream for single-dose intra-anal application
|
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts 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).
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr Hans-Jurgen Gruss, Norgine |
| ClinicalTrials.gov Identifier: | NCT01406925 History of Changes |
| Other Study ID Numbers: | NRL001-02/2006(SD) |
| Study First Received: | July 29, 2011 |
| Last Updated: | July 29, 2011 |
| Health Authority: | Bulgaria: Ministry of Health |
Additional relevant MeSH terms:
|
Fecal Incontinence Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013