Concert just completed a phase 1, multiple ascending dose study of CTP-656, with placebo. Some additional value can be found in the following press release from Concert regarding this study. Multiple Ascending Dose Phase 1.
Pharmacokinetics: "Across all doses, the average plasma half-life of CTP-656 was approximately 18 hours at steady state. CTP-656 showed a dose-proportional increase in exposure with repeated dosing for the 75 mg and 150 mg doses. The 225 mg dose group showed higher than dose-proportional exposure."
CTP-656 in the previous phase 1 oral solution trial, showed a half-life around 15 hours. So it looks like an improvement was seen with the solid dosing of CTP-656 over a seven day study, as it pertains to half-life. CTP-656 was well-tolerated and it's safety profile was comparable to that of Kalydeco.
Also within the press release "We are pleased to see that full bioavalability of CTP-656 was retained even with a low fat meal," stated Dr. Cassella.
Pharmacokinetics: "Across all doses, the average plasma half-life of CTP-656 was approximately 18 hours at steady state. CTP-656 showed a dose-proportional increase in exposure with repeated dosing for the 75 mg and 150 mg doses. The 225 mg dose group showed higher than dose-proportional exposure."
CTP-656 in the previous phase 1 oral solution trial, showed a half-life around 15 hours. So it looks like an improvement was seen with the solid dosing of CTP-656 over a seven day study, as it pertains to half-life. CTP-656 was well-tolerated and it's safety profile was comparable to that of Kalydeco.
Also within the press release "We are pleased to see that full bioavalability of CTP-656 was retained even with a low fat meal," stated Dr. Cassella.
Additional interest is that the company has announced that they will be participating in 39th European Cystic Fibrosis Conference being held June 8-11, 2016 in Basal Switzerland. Thank you for reading.
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