ONO-7746 Study in Healthy Adult Subject

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Drug: ONO-7746

Study type: Interventional

Funder types: Industry

Identifiers

NCT01106664

ONO-7746POU002

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of NON-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746 and to evaluate the food effect on the PK profile of ONO-7746 when administered with or without a meal.

Enrollment: 72 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 19-35 kg/m2 (inclusive)
• For females, postmenopausal, non-lactating, and non-pregnant

Exclusion criteria

• History or presence of clinically significant disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

P

Placebo Comparator group

Treatment:

Drug: ONO-7746

Drug: ONO-7746

E

Experimental group

Treatment:

Drug: ONO-7746

Drug: ONO-7746