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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
  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
Intervention Model: Crossover Assignment
Masking: Double Blind (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

Further study details as provided by Norgine:

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

Secondary Outcome Measures:
  • AUC of NRL001 [ Time Frame: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing ]
  • Tolerability of NRL001 [ Time Frame: Up to 12 hours post-dosing ]
    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   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406925

Locations
Bulgaria
University Hospital MHAPT Zaritza Johanna
Sofia, Bulgaria
Sponsors and Collaborators
Norgine
Investigators
Study Director: Hans Gruss, MD PhD Norgine
  More Information

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

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 23, 2017