Study to Examine the Effect of Ulimorelin on the Pharmacokinetics of Midazolam in Healthy Volunteers
An open-label, single centre, randomised, cross-over study to examine the effect of ulimorelin on the pharmacokinetics of midazolam after repeat dose administration of ulimorelin in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||An Open-label, Single Centre, Randomised, Cross-over Study to Examine the Effect of Ulimorelin on the Pharmacokinetics of Midazolam After Repeat Dose Administration of Ulimorelin in Healthy Volunteers|
- AUC(0 to infinity) of midazolam [ Time Frame: Pre-(midazolam)dose and 15, 30, 45 mins and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 and 30 hours post dose ] [ Designated as safety issue: No ]
- Cmax of Midazolam [ Time Frame: Pre-(midazolam)dose and 15, 30, 45 mins and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 and 30 hours post dose ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Those subjects to receive Treatment A will receive a single dose of midazolam on Day 1 and will be discharged from the study unit on Day 2, at least 30 hours after midazolam dosing.
Single oral administration on Day 1 or Day 5
Those subjects to receive Treatment B will receive once daily ulimorelin on Days 1 to 5. Midazolam will be administered on Day 5 with the last dose of ulimorelin and subjects will be discharged from the study unit on Day 6, at least 30 hours after midazolam dosing.
Intravenous infusion of 480 micrograms/kg on Days 1 to 5
Other Name: TZP101
Ulimorelin is a first-in-class new chemical entity. It is a ghrelin agonist with gastroprokinetic activity being developed as an intravenous therapy to be used in the treatment of gastrointestinal (GI) hypomotility disorders such as post-operative ileus (POI) and gastroparesis.
POI is a transient disruption of co-ordinated bowel motility that contributes to patient morbidity, discomfort and prolonged recovery times. POI most commonly occurs after abdominal surgery and annually, POI is the main determinant of length of hospital stay after major abdominal surgery and a factor in patient hospital re-admissions, increased healthcare resource use and cost, and decreased patient satisfaction. Current strategies to attenuate POI are aimed at enhanced recovery after surgery (ERAS) or "fast track". These are multimodal care protocols designed to reduce the impact of external and internal factors on POI duration. Recently, fewer complications and a quicker return to work and normal activities for patients who have had ERAS programmes implemented have been reported. In spite of these strategies only up to 20% of subjects undergoing partial bowel resection recover GI function within 72 hours after surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405612
|BioKinetic Europe Ltd|
|Belfast, United Kingdom, BT2 7BA|
|Study Director:||Maria Tomas, PhD||Norgine|