Healthy Adult Subjects
Conditions
Keywords
ONO-2950, healthy adult subjects, first in human, safety, tolerability, pharmacokinetics
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending single doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile of ONO-2952.
Interventions
DRUGONO-2952
3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study
DRUGPlacebo
Placebo dosed in the same manner as ONO-2952
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 19-35 kg/m2 (inclusive) * For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception
Exclusion criteria
* History or presence of clinically significant disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events | up to 8 days |
Secondary
| Measure | Time frame |
|---|---|
| Characterization of PK of ONO-2952 through measurement of drug concentration in plasma and urine sample | up to 8 days |
| Effect of food on ONO-2952 pharmacokinetics by comparison of PK profile between fasted and fed conditions | up to 24 days |
Countries
United States
Outcome results
None listed