drugset / Trial / NCT01297582
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950, pulmonary function, and potential cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a meal upon the pharmacokinetic profile of ONO-6950.
Timeline
- Start
- 2011-01
- Primary completion
- 2011-06
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | GEMILUKAST | Small molecule | 1 mg | — |
| Comparator | GEMILUKAST | Small molecule | 3 mg | — |
| Comparator | GEMILUKAST | Small molecule | 10 mg | — |
| Comparator | GEMILUKAST | Small molecule | 30 mg | — |
| Comparator | GEMILUKAST | Small molecule | 100 mg | — |
| Comparator | GEMILUKAST | Small molecule | 300 mg | — |
| Comparator | GEMILUKAST | Small molecule | 1000 mg | — |
Indications
No indication recorded.