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A phase 1, open-label, multicentre study to compare the capsule and tablet formulations of AZD5363 and explore the effect of food on the pharmacokinetic exposure, safety and tolerability of AZD5363 in patients with advanced solid malignancies: OAK.
Dean, Emma J Banerji, U Schellens, J Krebs, Matthew G Jimenez, B van Brummelen, E Bailey, C Casson, E Cripps, D Cullberg, M
Dean, Emma J
Banerji, U
Schellens, J
Krebs, Matthew G
Jimenez, B
van Brummelen, E
Bailey, C
Casson, E
Cripps, D
Cullberg, M
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Abstract
AZD5363 is a potent pan-AKT inhibitor originally formulated as a capsule; a tablet was developed for patient convenience and manufacturing ease. This study assessed the PK comparability of both formulations (Part A) and the effect of food (Part B) on the PK/safety of the tablet.
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2018-03-14
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A phase 1, open-label, multicentre study to compare the capsule and tablet formulations of AZD5363 and explore the effect of food on the pharmacokinetic exposure, safety and tolerability of AZD5363 in patients with advanced solid malignancies: OAK. 2018, Cancer Chemother Pharmacol