ONO-7746 Study in Healthy Adult Subject

Ono Pharmaceutical Co., Ltd.72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Adult Subjects

Interventions

ONO-7746DRUG

1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.

ONO-7746DRUG

1mg, 2mg, 4mg, 8mg, 16mg once daily for multiple-dose study; 4mg at a single dose for food effect study

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Austin Clinical Site

Austin, Texas, United States

Outcomes

Primary Outcomes

Safety Assessment

(evaluations of physical examinations, vital signs, 12-lead ECG, slit lamp examinations, safety laboratory tests, and surveillance for adverse events)

Time frame: up to 42 days

Secondary Outcomes

Characterization of PK and PD profiles, including platelet count changes of ONO-7746

Time frame: up to 42 days

Effect of food on ONO-7746 pharmacokinetics

Time frame: up to 42 days

Data from ClinicalTrials.gov

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