Effect of Repeated Doses of DS-8500a on Pharmacokinetics of Rosuvastatin in Healthy Volunteers

Phase 1 Completed 24 enrolled Daiichi Sankyo

SequentialOpen-labelBasic science

Summary

The primary purpose of this study is to assess the effect of repeated doses of DS-8500a on the single dose pharmacokinetics (PK) of rosuvastatin. The total length of time (from screening to follow-up) for each participant is approximately 7 weeks. It is expected that repeated oral doses of DS-8500a will not have a significant effect on the pharmacokinetics of a single dose of rosuvastatin.

Timeline

Start: 2015-05-12
Primary completion: 2015-07-06
Completion: 2015-07-06

Publications

Maekawa Y, Furuie H, Kato M, Myobatake Y, Kamiyama E, Watanabe A, Shiosakai K, Taguchi T, Bass R, Zhou J, Dishy V, Warren V, Vashi V, Ishizuka H. Effect of DS-8500a, a Novel G Protein-Coupled Receptor 119 Agonist, on the Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects. Clin Drug Investig. 2019 Oct;39(10):967-978. doi: 10.1007/s40261-019-00825-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FIRUGLIPEL	Small molecule	75 mg	Oral
Subject	Rosuvastatin	Small molecule	10 mg	Oral

Indications

No indication recorded.