An Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be
participating in this study. This study is composed of 2 parts:
Part 1 is a dose finding study. Part 2 is a pharmacodynamic and pharmacokinetic study of an
elected dose. A screening will be used to determine patients' suitability for inclusion in
the trial. Within one week after the screening visit, subjects who meet all inclusion
criteria and none of the exclusion criteria will enter part 1 of the study, one day of dose
escalation. During this part, patients will undergo rectal manometry to determine anal
pressure at baseline. Afterwards coated suppositories at various drug concentrations will be
inserted and follow up manometries will be performed to determine response.
Patients that presented with an increase in rectal resting pressure without adverse events
will enter the second part of the study. In this part, patients will be administered with a
coated suppository, at a dose found at part 1 of the study to cause significant anal
contraction. Manometry studies will be performed before insertion (baseline) and at 1, 3 and
5 hours after insertion.
Blood levels for drug concentrations will be taken at times 0, 30, 60, 120, 180, 300 minutes
after administration and rectal manometries will be done at times 0, 1, 3 and 5 hours after
administration.