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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406925
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : August 1, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Drug: Placebo control Drug: NRL001 cream Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : April 2007
Actual Primary Completion Date : May 2007
Actual Study Completion Date : June 2007

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Cmax of NRL001 [ Time Frame: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing ]

Secondary Outcome Measures :
  1. AUC of NRL001 [ Time Frame: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing ]
  2. Tolerability of NRL001 [ Time Frame: Up to 12 hours post-dosing ]
    Spontaneously reported adverse events will be recorded

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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:


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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01406925

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University Hospital MHAPT Zaritza Johanna
Sofia, Bulgaria
Sponsors and Collaborators
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Study Director: Hans Gruss, MD PhD Norgine
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Responsible Party: Dr Hans-Jurgen Gruss, Norgine Identifier: NCT01406925    
Other Study ID Numbers: NRL001-02/2006(SD)
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: August 1, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases