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drugset / Trial / NCT02433457

Relative Bioavailability Study of CC-292

NCT02433457 ↗

Phase 1 Completed 24 enrolled Celgene Corporation

RandomizedCrossoverOpen-labelTreatment

Summary

To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292 P22 tablet.

Timeline

Start: 2014-05-26
Primary completion: 2014-09-26
Completion: 2014-09-26

Publications

Cheng Y, Liu L, Xue Y, Zhou S, Li Y. An Open Label, Phase 1, Randomized, Seven-treatment, Seven-period, Crossover Study to Assess the Relative Bioavailability, pH Effect, Food Effect, and Dose Proportionality of CC-292, a Potent and Orally Available Bruton's Tyrosine Kinase Inhibitor. Eur J Drug Metab Pharmacokinet. 2022 Jul;47(4):579-592. doi: 10.1007/s13318-022-00776-7. Epub 2022 Jun 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omeprazole	Other / unclassified	40 mg	Oral
Subject	Spebrutinib	Small molecule	100 mg	Oral
Subject	Spebrutinib	Small molecule	300 mg	Oral
Subject	Spebrutinib	Small molecule	375 mg	Oral

Indications

No indication recorded.