NCT01405651

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

A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ono Pharma USA Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	ONO-6950	30 mg, 100 mg, 300 mg at multiple doses
DRUG	ONO-6950	Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-10-01
• First posted: 2011-07-29
• Last updated: 2012-06-14

Locations

1 site across 1 country: United States