Cytochroma Begins Trial of CTAP101 Capsules

Canadian drugmaker Cytochroma has started dosing in a Phase I/II clinical trial of CTAP101 capsules for the treatment of vitamin D insufficiency in chronic kidney disease (CKD).

The four-week, open-label trial will establish the pharmacokinetic profile and safety of CTAP101 capsules. The product’s pharmacokinetic profile will be characterized at low-, mid- and high-dosages in subjects with normal renal function and at a single mid-dosage in subjects with Stage 3 and 4 CKD.

Joel Melnick, Cytochroma’s vice president of clinical and regulatory affairs, said the capsules are designed to address the marginal effectiveness of high-dose vitamin D2 in treating vitamin D insufficiency in CKD while providing an alternative to off-label use of vitamin D hormone replacement therapies.