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Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of 7.5, 10, 12.5 or 15 mg NRL001 in a 2 g Suppository for 14 Days

Fecal Incontinence Clinical Trial

Official title:
A Double-blind, Placebo-controlled, Randomised, Parallel-group, Dose-escalating, Repeat Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of the Once Daily Rectal Application of 7.5, 10, 12.5 or 15 mg NRL001 in a 2 g Suppository for 14 Days

Clinical Trial Summary

Healthy subjects will receive NRL001 or placebo once daily for 14 days. The four treatment groups, shown below, will each consist of 12 subjects:

Group 1; Nine subjects will receive a dose of 7.5 mg NRL001 in a 2 g suppository and three will receive matching placebo.

Group 2; Nine subjects will receive a dose of 10 mg NRL001 in a 2 g suppository and three will receive matching placebo.

Group 3; Nine subjects will receive a daily dose of 12.5 mg NRL001 in a 2 g suppository and three will receive matching placebo.

Group 4; Nine subjects will receive a daily dose of 15 mg NRL001 in a 2 g suppository and three will receive matching placebo.

The dosing of each group will be completed prior to the next group being dosed. Dose escalation will be dependent on a positive assessment of the safety profile of the preceding group by the Safety Monitoring Board.

The pharmacokinetics of NRL001 will be determined on Days 1, 7 and 14. Pharmacodynamics will be examined using a three lead Holter monitor at screening and at intervals throughout the study period. Adverse events, vital signs, ECGs and clinical laboratory parameters will be collected, tabulated, reviewed and recorded throughout the study.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01099670
Study type Interventional
Source Norgine
Contact
Status Completed
Phase Phase 1
Start date March 2010
Completion date June 2010
View Details
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