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Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT01406925
First received: July 29, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted

July 29, 2011
July 29, 2011
April 2007
May 2007   (final data collection date for primary outcome measure)
Cmax of NRL001 [ Time Frame: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fecal Incontinence
  • Drug: Placebo control
    Placebo cream
  • Drug: NRL001 cream
    Cream for single-dose intra-anal application
  • Placebo Comparator: Control
    Placebo control
    Intervention: Drug: Placebo control
  • Experimental: Low dose NRL001
    0.5% NRL001 cream
    Intervention: Drug: NRL001 cream
  • Experimental: Intermediate dose NRL001
    0.75% NRL001 cream
    Intervention: Drug: NRL001 cream
  • Experimental: High dose NRL001
    1.0% NRL001 cream
    Intervention: Drug: NRL001 cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2007
May 2007   (final data collection date for primary outcome measure)

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).

Both
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Bulgaria
 
NCT01406925
NRL001-02/2006(SD)
No
Dr Hans-Jurgen Gruss, Norgine
Norgine
Not Provided
Study Director: Hans Gruss, MD PhD Norgine
Norgine
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP