Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers
Tracking Information | |||||
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First Received Date ICMJE | July 29, 2011 | ||||
Last Updated Date | July 29, 2011 | ||||
Start Date ICMJE | April 2007 | ||||
Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Cmax of NRL001 [ Time Frame: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers | ||||
Official Title ICMJE | 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 | ||||
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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Fecal Incontinence | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 12 | ||||
Completion Date | June 2007 | ||||
Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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). |
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Gender | Both | ||||
Ages | 21 Years to 50 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Bulgaria | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01406925 | ||||
Other Study ID Numbers ICMJE | NRL001-02/2006(SD) | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Dr Hans-Jurgen Gruss, Norgine | ||||
Study Sponsor ICMJE | Norgine | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Norgine | ||||
Verification Date | July 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |