Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

Phase 1 Completed 48 enrolled Ono Pharma USA Inc

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending single doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile of ONO-2952.

Timeline

Start: 2011-05
Primary completion: 2011-08
Completion: —

Publications

Suto F, Wood AT, Kobayashi M, Komaba J, Duffy K, Bruce M. Safety, Tolerability, and Pharmacokinetic Profile of the Novel Translocator Protein 18 kDa Antagonist ONO-2952 in Healthy Volunteers. Clin Ther. 2015 Sep;37(9):2071-84. doi: 10.1016/j.clinthera.2015.07.010. Epub 2015 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ONO-2952	Small molecule	3 mg	—
Subject	ONO-2952	Small molecule	10 mg	—
Subject	ONO-2952	Small molecule	30 mg	—
Subject	ONO-2952	Small molecule	100 mg	—
Subject	ONO-2952	Small molecule	200 mg	—
Subject	ONO-2952	Small molecule	400 mg	—
Subject	ONO-2952	Small molecule	800 mg	—

Indications

No indication recorded.