Experimental: Treatment Group
Azeliragon will be orally administered to 3 groups of 6 subjects, with escalation of dosing occurring with each subsequent group.
Dose Level 1 consists of a loading dose of 15mg once daily for 6 days, followed by a continuous dose of 5mg once daily for the remainder of the study.
Dose Level 2 consists of a loading dose of 15mg twice daily for 6 days, followed by a continuous dose of 10mg once daily for the remainder of the study.
Dose Level 3 consists of a loading dose of 30mg twice daily for 6 days, followed by a continuous dose of 20mg once daily for the remainder of the study.
Escalation will continue until stopping rules are met or the highest defined dose level is reached. The trial will be closed to accrual if the first dose level is deemed intolerable.
Drug: Azeliragon
Azeliragon is an orally administered inhibitor of Receptor for Advanced Glycation Endproducts (RAGE) which is formulated as a 5mg hard gelatin capsule.
Other Name: TTP488
Source: View full study details on ClinicalTrials.gov
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