Evaluation of Single Doses of GSK962040 in Critically Ill Patients With Enteral Feed Intolerance (NCT01039805) | Clinical Trial Compass
CompletedPhase 2
Evaluation of Single Doses of GSK962040 in Critically Ill Patients With Enteral Feed Intolerance
Australia34 participantsStarted 2009-12
Plain-language summary
The aims of MOT112571 are to assess the pharmacodynamic effects, safety, tolerability, pharmacokinetics, and potential therapeutic benefit of single doses of GSK962040 in critically ill patients with delayed gastric emptying and who are intolerant to enteral feeding.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female between 18-85 years of age, at the time consent is obtained.
* Mechanically ventilated on the Intensive Care Unit who has become intolerant of nasogastric enteral feeding.
* intolerance of nasogastric tube feeding is defined as a gastric aspirate volume (GRV) \>250 mL at least 6 hours after commencing feeding at \>40 mL/hr.
* Expected to remain mechanically ventilated for at least 48 hours after enrollment and expected to survive for at least 24 hours post dose of study medication.
* Subject has a nasogastric tube for enteral feeding.
* Body weight \> or = 50 kg
* Written informed consent may be obtained from a legally acceptable representative, which includes compliance with the requirements and restrictions listed in the consent form. In most cases, consent will be sought from next of kin as the subject will not be competent to give their own consent.
* Average QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.
* AST and ALT \< 3xULN; alkaline phosphatase and bilirubin \< or = 2xULN.
* Subjects who have rapidly rising aminotransferases or for whem there is not a plausible explanation for the observed elevation will not be enrolled
* LFTs will be checked for eligibility on screening and again prior to dosing with GSK962040.
Exclusion Criteria:
* Subjects that have received a gastric prokinetic agent in the previous 24 h (e.g., erythromycin, azithromycin, metoclopramide). These agents are prohibited for t…
What they're measuring
1
Gastric emptying
Timeframe: 3 days
2
Safety and tolerability of GSK962040
Timeframe: 5 days
3
Pharmacokinetic parameters of GSK962040: Cmax, Tmax, AUC(0-inf), AUC(0-t), CL/F, V/F, and half-life