FDA Places Hold on Idenix Trials, Citing Elevated Liver Enzymes

The FDA has placed Idenix’s clinical trials for its hepatitis C treatments on hold after elevated liver enzymes were noted. Idenix says it was notified verbally Sept. 3 that the trials of IDX184 and IDX320 have been placed on clinical hold. No healthy volunteers or patients are currently receiving IDX184 or IDX320, Idenix adds. The serious adverse events were noted during a Phase I drug-drug interaction study of a combination of IDX184 and IDX320 in healthy volunteers during post-exposure safety visits. The liver function tests returned to nearly normal levels in all three subjects during follow-up.
Clinical Trials Advisor