Biotech Values

[DewDiligence]

IDIX’s drug-drug-interaction study of IDX184+IDX320 is close to dosing the first subject insofar as clinicaltrials.gov (as of Jul 2) now has an entry for this trial at http://clinicaltrials.gov/ct2/show/NCT01157104 . (Thanks to the new iHub poster, delmar512, for this find.) I expect IDIX to issue a PR when the first subject in this trial has been dosed.

The trial design is typical for a 2-drug DDI study. In each of two 8-subject cohorts, subjects take IDX184 or IDX320 monotherapy in the first week and switch to IDX184+IDX320 combination therapy in the second week; this design allows the PK/PD of the drug combination to be distinguished from the PK/PD of each drug individually.

During the one-week monotherapy period, subjects receive a lookalike placebo for the drug they are not taking, which enables the subjects and clinicians to be blinded from the treatment protocol of a given subject. Each of the two cohorts also has two subjects who take placebos throughout the 2-week dosing period, which means there are 20 subjects in all (2x(8+2)).

Viral resistance is a non-issue in this trial because the subjects are healthy volunteers, not HCV patients.

The one trial center already listed at clinicaltrials.gov is in Lincoln, NE, which is where the main campus of University of Nebraska is located. College students are presumably a good source of volunteers for these kinds of studies.

Please see #msg-49731578 and #msg-49732533 for background info on where all-oral IDX184+IDX320 combination treatment fits into IDIX’s plans in the HCV arena.