Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

Completed · Phase 1

Conditions studied: Healthy Adult Subjects

In brief

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.

Key facts

Study ID

NCT01297582

Run by

Ono Pharma USA Inc

People needed

56

Starts

2011-01-01

Last updated by the study team

2012-06-14

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 19-35kg/m2 (inclusive)
• For females, postmenopausal, non-lactating, and non-pregnant

You may not qualify if…

• History or presence of clinical significant disease

Where it is running

• Miramar Clinical Site — Miramar, Florida, United States

Full record on ClinicalTrials.gov

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