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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

NCT01099670 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2010-12-24

No results posted yet for this study

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

DRUG

NRL001

Rectal suppository Placebo

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • David Bell, MRCGP MFPM · Bio-Kinetic Europe, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT01099670 on ClinicalTrials.gov