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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Adult Subjects

In brief

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.

Key facts

Study ID

NCT01364441

Run by

Ono Pharma USA Inc

People needed

48

Starts

2011-05-01

Last updated by the study team

2012-06-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy non-smoking male or female subjects (18-55 inclusive)
• Body mass index (BMI) of 19-35 kg/m2 (inclusive)
• For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception

You may not qualify if…

• History or presence of clinically significant disease

Where it is running

• Austin Clinical Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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