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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P | Placebo Comparator |
| |
| E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-2952 | Drug | 3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study |
| |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharma USA, Inc. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Clinical Site | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26249232 | Derived | Suto F, Wood AT, Kobayashi M, Komaba J, Duffy K, Bruce M. Safety, Tolerability, and Pharmacokinetic Profile of the Novel Translocator Protein 18 kDa Antagonist ONO-2952 in Healthy Volunteers. Clin Ther. 2015 Sep;37(9):2071-84. doi: 10.1016/j.clinthera.2015.07.010. Epub 2015 Aug 4. |
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| ID | Term |
|---|---|
| C000607300 | ONO-2952 |
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| Placebo |
| Drug |
Placebo dosed in the same manner as ONO-2952 |
|