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The primary objectives of the study are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RhuDex | Drug | Part 1: Regimen A: Rhudex Formulation in Labrafac/ Gelucire Regimen B: Rhudex Formulation in Labrafac/ Aerosil single dose The formulation platform (A or B) that shows the best potential to achieve the target PK profile and shows acceptable safety and tolerability will be progressed into part 2 of the study. The purpose of part 2 is to optimize the selected formulation platform. This will be achieved by administrating up to four different formulation compositions. |
| Measure | Description | Time Frame |
|---|---|---|
| PK blood samples | All target PK evaluations will be made on the basis that the optimal plasma PK profile will be characterised by a plasma Cmax < 5000 ng/mL, an elimination half-life of > 8h and a C(last) (24h) of around 800-1000 ng/mL. Formulations will explicity not be selected based on determinations of Cmax or AUC(0-inf) alone | taken predose, 0.5 h - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8- 12- 24 -48 - 72 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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