Healthy Adult Subjects
Conditions
Keywords
ONO-6950, Healthy Adult Subjects
Brief summary
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.
Interventions
DRUGONO-6950
1mg, 3mg, 10mg, 30mg,100mg,300mg,1000mg at a single dose; 30mg, 100mg and 300mg for food effect study
Sponsors
Ono Pharma USA Inc
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 19-35kg/m2 (inclusive) * For females, postmenopausal, non-lactating, and non-pregnant
Exclusion criteria
* History or presence of clinical significant disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations | up to 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Characterization of PK and PD profiles of ONO-6950, including change from baseline in pulmonary function tests, and any potential cardiovascular effects | up to 7 days |
| Effect of food on ONO-6950 pharmacokinetics by comparison of PK profile between fasted and fed conditions | up to 15 days |
Countries
United States
Outcome results
None listed