GKT137831 safe/well tolerated in Phase I trial
At Kidney Week 2012, the 45th Annual Meeting of the American Society of Nephrology (ASN), held from 30th October to 4th November, in San Diego, CA, Phase I studies demonstrated excellent safety and tolerability following single and multiple oral doses of GenKyoTex' GKT137831, the first-in-class NOX 1 and 4 inhibitor. In addition, GKT137831 demonstrated a favourable pharmacokinetic (PK) profile in these subjects.
GKT137831 was found to be safe and well tolerated when administered orally to a total of 72 healthy adult males, at single doses of up to 1,800mg once daily and at multiple doses of up to 900mg once daily for ten days. No safety signals were identified and dose limiting toxicities were not reached. Orally-administered GKT137831 is rapidly absorbed and has a broadly dose-proportional PK over the 10 to 900mg dose range. Multiple dose administration does not modify the PK of GKT137831 and there is no accumulation.
The company is now planning the initiation of Phase II studies, including the evaluation of oral GKT137831 in patients with diabetic nephropathy, the lead indication.