Healthy Adult Subjects
Conditions
Keywords
ONO-7746, Healthy adult subjects
Brief summary
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.
Interventions
DRUGONO-7746
1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | up to 42 days | (evaluations of physical examinations, vital signs, 12-lead ECG, slit lamp examinations, safety laboratory tests, and surveillance for adverse events) |
Secondary
| Measure | Time frame |
|---|---|
| Characterization of PK and PD profiles, including platelet count changes of ONO-7746 | up to 42 days |
| Effect of food on ONO-7746 pharmacokinetics | up to 42 days |
Countries
United States
Outcome results
None listed