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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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This is a single center, randomized, open-label, three-way crossover, single dose, pharmacokinetic dose proportionality study of oral OPL-002 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPL-002 SDD 20 mg | Experimental | 20 mg SDD formulation of OPL-002 |
|
| OPL-002 5 mg Tablet | Experimental | 5 mg tablet formulation of OPL-002 |
|
| OPL-002 20 mg Tablet | Experimental | 20 mg tablet formulation of OPL-002 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPL-002 | Drug | Spray dried dispersion and tablet formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC of OPL-002 | 0 to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Dose proportionality of 5 and 20 mg | 0 to 48 hours | |
| Absolute lymphocyte count | 0 to 48 hours |
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Inclusion Criteria:
Male or female (of non-childbearing potential only) between 18 and 55 years of age.
Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:
Male subjects must use reliable forms of contraception from screening to 30 days after the end of dosing.
Good general health as determined by medical history, and by results of physical examination, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Gregg, MD | Oppilan Pharma Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Belfast | Northern Ireland | BT9 6AD | United Kingdom |
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