MedTrace Logo

Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers

NCT01406925 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-08-01

No results posted yet for this study

Summary

This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.

Conditions

  • Fecal Incontinence

Interventions

DRUG

Placebo control

Placebo cream

DRUG

NRL001 cream

Cream for single-dose intra-anal application

Sponsors & Collaborators

Principal Investigators

  • Hans Gruss, MD PhD · Norgine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2007-05-31
Completion
2007-06-30

Countries

  • Bulgaria

Study Locations

More Related Trials

Entities

Companies

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 NCT01406925 on ClinicalTrials.gov