Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers
NCT ID: NCT01406925
Last Updated: 2011-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2007-04-30
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Control
Placebo control
Placebo control
Placebo cream
Low dose NRL001
0.5% NRL001 cream
NRL001 cream
Cream for single-dose intra-anal application
Intermediate dose NRL001
0.75% NRL001 cream
NRL001 cream
Cream for single-dose intra-anal application
High dose NRL001
1.0% NRL001 cream
NRL001 cream
Cream for single-dose intra-anal application
Interventions
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Placebo control
Placebo cream
NRL001 cream
Cream for single-dose intra-anal application
Eligibility Criteria
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Inclusion Criteria
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
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).
21 Years
50 Years
ALL
Yes
Sponsors
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Norgine
INDUSTRY
Responsible Party
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Norgine
Principal Investigators
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Hans Gruss, MD PhD
Role: STUDY_DIRECTOR
Norgine
Locations
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University Hospital MHAPT Zaritza Johanna
Sofia, , Bulgaria
Countries
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Other Identifiers
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NRL001-02/2006(SD)
Identifier Type: -
Identifier Source: org_study_id
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