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

NCT01406925 | Completed Phase 1

• 1 other identifier: NRL001-02/2006(SD)
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Cmax of NRL001

  30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing

Secondary Outcomes (2)

• AUC of NRL001

  30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing

• Tolerability of NRL001

  Up to 12 hours post-dosing

Study Arms (4)

Control

PLACEBO COMPARATOR

Placebo control

Drug: Placebo control

Low dose NRL001

EXPERIMENTAL

0.5% NRL001 cream

Drug: NRL001 cream

Intermediate dose NRL001

EXPERIMENTAL

0.75% NRL001 cream

Drug: NRL001 cream

High dose NRL001

EXPERIMENTAL

1.0% NRL001 cream

Drug: NRL001 cream

Interventions

Placebo control DRUG

Placebo cream

Control

NRL001 cream DRUG

Cream for single-dose intra-anal application

High dose NRL001; Intermediate dose NRL001; Low dose NRL001

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• IN.1) sex: male and female (non-child-bearing potential or using medically adequate contraception
• IN.2) race: Caucasian
• IN.3) BW: 50 - 100 kg
• IN.4) BMI: 20 - 28 kg.m-2
• IN.5) age: 21 - 50 years
• IN.6) type: healthy on the basis of specified criteria evaluated at the screening visit
• IN.7) willing and able to provide informed consent

You may not qualify if:

• General
• EX.1) Previous participation in the trial
• EX.2) Participant in any other trial during the last 90 days
• EX.3) Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
• EX.4) History of any clinically relevant allergy (including hypersensitivity to the trial medications)
• EX.5) Presence of acute or chronic infection
• EX.6) Presence or history of any relevant co-morbidity
• EX.7) Resting systolic blood pressure \> 140 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
• EX.8) Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular
• EX.9) Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
• EX.10) Positive serology for HBsAg, anti HBc and anti HCV
• EX.11) Positive HIV test
• EX.12) Positive alcohol or urine drug test on recruitment (and upon admission)
• EX.13) History of alcohol and/or drug abuse and/or daily use of \> 30 gr alcohol
• EX.14) Smoking more than 15 cigarettes/day or equivalent of other tobacco products

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

University Hospital MHAPT Zaritza Johanna

Sofia, Bulgaria

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Hans Gruss, MD PhD

  Norgine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 1, 2011
• Study Start: April 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2007
• Last Updated: August 1, 2011

Record last verified: 2011-07

Locations

BU (1)