Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of a Single Rectal Application of 10 mg NRL001 in Elderly Subjects

December 23, 2010 updated by: Norgine

A Double-blind, Randomised, Placebo-controlled Study in Elderly Subjects to Evaluate the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of a Single Rectal Application of 10 mg NRL001 in a 2 g Suppository

A total of 26 healthy elderly male and female subjects will receive both 10 mg NRL001 in a 2 g rectal suppository and placebo in this double-blind, cross-over study. The order of treatment will be randomised, with a minimum washout period of 3 days between doses. An end of study assessment will be conducted at least 7 days after administration of the last treatment.

The pharmacokinetics of NRL001 will be determined prior to, and after, dosing. Pharmacodynamics will be examined using a three lead Holter monitor during both treatment periods. Adverse Events, vital signs, ECGs and clinical laboratory parameters will be collected, tabulated, reviewed and recorded throughout the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Belfast, United Kingdom, BT2 7BA
        • Bio-Kinetic Europe Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Volunteers will be included in the study if they satisfy the following criteria:

  • Healthy adult male or female volunteers (as determined by medical history, physical examination, laboratory test values, vital signs and electrocardiograms [ECGs] at screening) aged ≥65 years.
  • Non-smokers from 3 months before receiving the first dose and for the duration of the study.
  • Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2.
  • Able and willing to receive rectal treatments.
  • Able to voluntarily provide written informed consent to participate in the study.
  • Sexually active male volunteers must use condoms with their partners throughout the study and for 90 days after completion of the study in addition to their partner's normal mode of contraception.
  • Male volunteers must not donate sperm during the study and for 90 days after completion of the study.
  • Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol.
  • Female volunteers must be postmenopausal (for at least 1 year, confirmed by FSH testing at screening).
  • Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
  • The volunteer's primary care physician must confirm that there is nothing in their medical history that would preclude their enrolment into this clinical study.

Exclusion Criteria:

Volunteers will be excluded if they fulfil any of the following criteria:

  • Positive for HIV, hepatitis B, or hepatitis C as demonstrated by the results of testing at screening.
  • History or presence of any significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal (GI), endocrine or immunologic disease.
  • History or presence of any clinically significant ano-rectal conditions as judged by the Investigator (e.g. concomitant enlarged symptomatic haemorrhoids or acute presence of anal fissures) or clinically significant drug allergy.
  • Blood pressure in excess of 150/90 mmHg or pulse rate below 50 beats per minute at screening.
  • Any significant illness during the screening period preceding entry into this study.
  • Clinically relevant ECG-abnormalities (e.g. QTc prolongation, acute arrhythmia) during the screening assessment
  • Laboratory values which are abnormal and deemed to be clinically significant according to Bio-Kinetic Europe Ltd. SOPs, unless agreed in advance by the Sponsor's Responsible Medical Officer and the Bio-Kinetic Investigator.
  • Current or history of drug or alcohol abuse or a positive drugs of abuse test at screening or check in.
  • Use of any disallowed concomitant medication, including over-the-counter items within 14 days prior to study drug administration until the end of the study.
  • Use of any medication applied via the rectum, within 30 days prior to dosing
  • Use of any medication currently or within 30 days prior to dosing which the Investigator believes may affect the study participation or results.
  • Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
  • Donation of blood or blood products within 90 days prior to study drug administration, or at anytime during the study, except as required by this protocol.
  • History of any allergy to medication, particularly nifedipine, α adrenoceptor antagonists or latex
  • Consumption of alcoholic beverages within 24 hours prior to each dosing period. Abstinence is required during study confinement.
  • Consumption of xanthine-containing products within 24 hours of each dosing period and during study confinement.
  • Subjects who are considered not competent to consent to the trial or fail a Mini Mental State Exam (MMSE).
  • Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NRL001
All subjects will receive 10 mg NRL001 in a 2 g rectal suppository
Single rectal administration of 2 mg NRL001 in a 2 g suppository
PLACEBO_COMPARATOR: Placebo
All subjects will receive placebo
All subjects will receive rectal suppository containing placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic effects of NRL001
Time Frame: 4 hours post-administration
4 hours post-administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of NRL001
Time Frame: 30 hours post-administration
30 hours post-administration
Safety will be assessed by recording adverse events (AEs), vital signs, 12-lead ECG, physical examinations and clinical laboratory tests.
Time Frame: Throughout the study period
Throughout the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: David Bell, MRCGP MFPM, Bio-Kinetic Europe, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

February 15, 2010

First Submitted That Met QC Criteria

April 6, 2010

First Posted (ESTIMATE)

April 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2010

Last Update Submitted That Met QC Criteria

December 23, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • NRL001-02/2009 (SAGE)
  • 2009-017475-16 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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