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drugset / Trial / NCT01537172

A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers

NCT01537172 ↗

Phase 1 Completed 80 enrolled Ono Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects. The secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053 in healthy adult male and female subjects.

Timeline

Start
2012-01
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject ONO-4053 Unknown 10 mg Oral
Subject ONO-4053 Unknown 30 mg Oral
Subject ONO-4053 Unknown 100 mg Oral
Subject ONO-4053 Unknown 300 mg Oral
Subject ONO-4053 Unknown 600 mg Oral
Subject ONO-4053 Unknown 900 mg Oral

Indications

No indication recorded.