NCT01364441

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

A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (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-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.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	ONO-2952	3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study
DRUG	Placebo	Placebo dosed in the same manner as ONO-2952

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-08-01
• First posted: 2011-06-02
• Last updated: 2012-06-13

Locations

1 site across 1 country: United States