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

NCT01099683 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-12-24

No results posted yet for this study

Summary

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.

Conditions

  • Fecal Incontinence

Interventions

DRUG

NRL001

Single rectal administration of 2 mg NRL001 in a 2 g suppository

DRUG

Placebo

All subjects will receive rectal suppository containing placebo

Sponsors & Collaborators

Principal Investigators

  • David Bell, MRCGP MFPM · Bio-Kinetic Europe, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01099683 on ClinicalTrials.gov