drugset / Trial / NCT01405651

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

NCT01405651

Phase 1 Completed 24 enrolled Ono Pharma USA Inc
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending multiple doses in healthy adult male and female subjects. The secondary objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by measuring plasma concentrations of ONO-6950 and pulmonary function.

Timeline

Start
2011-07
Primary completion
2011-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator GEMILUKAST Small molecule 30 mg
Comparator GEMILUKAST Small molecule 100 mg
Comparator GEMILUKAST Small molecule 300 mg

Indications

No indication recorded.