NCT06593730

Safety and Tolerability of the Twice Daily Intra-anal Application of NRL001 Cream for 14 Days

Double-blind, Placebo-controlled, Randomised, Parallel-group Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Twice Daily Intra-anal Application of NRL001-cream for 14 Days.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The study is being conducted to evaluate the safety and tolerability after single and repeated twice daily intra-anal applications of 1mL NRL001 cream in stepwise increasing concentrations.

Detailed description

Single-centre, randomised, placebo-controlled, double-blind, repeated dose study in healthy male and female volunteers, comprising up to six sequential dose groups receiving 1 mL doses of an investigational cream formulation containing 0.50, 0.75, 1.00, 1.50, 2.00 and 2.50% w/w NRL001. Doses were to be investigated in stepwise increasing fashion. Progression to a higher dose-step required completion of the previous dose-step without safety limiting findings. Each dose-step was to be investigated in 12 subjects; in each dose-group, subjects assigned to active treatment were to be studied in parallel with subjects assigned to placebo in double-blind fashion with random (9:3) treatment assignment. Each subject was to be studied for one study period with double-blind investigational treatment (1 mL of an investigational cream formulation containing NRL001 or matched placebo) twice daily from the morning of D01 to the afternoon of D14; this phase was to be preceded by a single-blind placebo control day (D-1) with administration of placebo in the morning and afternoon.

Conditions

• Faecal Incontinence

Interventions

Type	Name	Description
DRUG	NRL001 cream 0.5%w/w
DRUG	NRL001 cream 0.75%w/w
DRUG	NRL001 cream 1.0%w/w
DRUG	NRL001 cream 1.5%w/w
DRUG	NRL001 cream 2.0%w/w
DRUG	NRL001 cream 2.5%w/w

Timeline

• Start date: 2007-08-01
• Primary completion: 2007-08-01
• Completion: 2007-09-01
• First posted: 2024-09-19
• Last updated: 2024-09-19