NCT01099670

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DRUG	NRL001	Rectal suppository Placebo
DRUG	Placebo	Placebo

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-04-07
• Last updated: 2010-12-24

Locations

1 site across 1 country: United Kingdom