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Sponsored by: |
Norgine |
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Information provided by: | Norgine |
ClinicalTrials.gov Identifier: | NCT00850590 |
Studies investigating single doses of different NRL001 formulations showed formulation-dependent differences in exposure, even though they had similar effects on mean anal resting pressure (MARP). This study is a first step in investigating the hypothesis that a better balance between desired anal effects and undesired systemic effects can be reached with a NRL001-slow release suppository than with previously studied formulations.
To this purpose, single doses of 5 to 15 mg, administered as 1 g and 2 g suppositories, are being investigated with regard to their pharmacokinetics and systemic effects (blood pressure, pulse rate, electrocardiographic heart rate).
Condition | Intervention | Phase |
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Incontinence |
Drug: NRL001 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Randomised, Placebo-Controlled, Double-Blind, Dose Escalation Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of Rectal Suppositories Containing Between 5 and 15 mg NRL001 or Matching Placebo for Two Different Sized Suppositories (1 g and 2 g). |
Estimated Enrollment: | 48 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Low Dose: Experimental
NRL001 at 5, 7.5, and 10 mg administered in a dose escalating manner with placebo in a random position in the sequence. NRL001 is contained in either a 1 g or a 2 g slow release rectal suppository.
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Drug: NRL001
Four single doses of NRL001 or placebo. NRL001 is administered at lower (5, 7.5 and 10 mg) or higher (10, 12.5 and 15 mg) doses in a slow release rectal suppository weighing either 1 g or 2 g.
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High Dose: Experimental
NRL001 at 10, 12.5, and 15 mg administered in a dose escalating manner with placebo in a random position in the sequence. NRL001 is contained in either a 1 g or a 2 g slow release rectal suppository.
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Drug: NRL001
Four single doses of NRL001 or placebo. NRL001 is administered at lower (5, 7.5 and 10 mg) or higher (10, 12.5 and 15 mg) doses in a slow release rectal suppository weighing either 1 g or 2 g.
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Bio-Kinetic Europe Limited | Recruiting |
Belfast, United Kingdom, BT2 7BA | |
Contact: David Bell, MRCGP MFPM +44 (0) 28 9081 8381 | |
Principal Investigator: Bell David, MRCGP MFPM |
Study Director: | Hans-Jürgen Gruss, MD | Norgine |
Principal Investigator: | David Bell, MRCGP MFPM | Biokinetic Europe Ltd |
Responsible Party: | Norgine Ltd ( VP Clinical Development ) |
Study ID Numbers: | NRL001-02/2008 (SUSD) |
Study First Received: | February 23, 2009 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00850590 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Body Weight Signs and Symptoms Urologic Diseases |
Urination Disorders Urinary Incontinence Healthy |
Signs and Symptoms Urological Manifestations Urologic Diseases Urination Disorders Urinary Incontinence |