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

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Drug: ONO-6950

Study type: Interventional

Funder types: Industry

Identifiers

NCT01297582

ONO-6950POU001

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• History or presence of clinical significant disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

E

Experimental group

Treatment:

Drug: ONO-6950

P

Placebo Comparator group

Treatment:

Drug: ONO-6950