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Tuesday, September 22, 2015 9:57:46 PM
The 004 ph2a is still fully geared towards pk knowlege. The goals of trial are all officially pk, but that doesnt mean they won't share other data obtained. It really just means they have little to fail here. It's an information gathering study. What is effect of 004 on pk of IV ceftriaxone in patients with functioning ileostomy? Measure ceftriaxone pk maximum with and without presence of 004. Ceft concentration curve measurements with and without 004. Ceft time to reach peak plasma concentration with and without 004. (Couldn't copy these goals from clinicaltrials.gov so paraphrased. Please forgive.) Anyway - officially, study set up as pure info gathering. About the only thing other than safety concern that would cause them to not move on would be negative effect on ceftriaxone in presence of low and high dose syn004 (with or without presence of proton pump inhibitor). And we already know that risk has been ruled out. Hypothetical example:if they discovered in this trial that high dose 004 impaired action of ceft or entered bloodstream with ceft and altered some of the pharmacokinetics of the antibiotic, they could still move on though technically that would be failure. They are early enough in trials to alter dose according to pk findings. But they wont need to.
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