Healthy
Conditions
Keywords
ONO-2952, Healthy adult subjects, Multiple dose, Safety, Tolerability, Pharmacokinetics
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending multiple doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.
Interventions
DRUGONO-2952
30 mg to 100 mg QD at a multiple dose, and 21 days duration
30 mg to 100 mg QD at a multiple dose, and 21 days duration
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 | 36 days |
Secondary
| Measure | Time frame |
|---|---|
| Characterization of PK of ONO-2952 in plasma samples | 36 days |
Countries
United States
Outcome results
None listed